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An automated medication preparation system for preparing a prescribed
dosage of medication in a drug delivery device includes a plurality of
stations for receiving, handling and processing the drug delivery device
so that the prescribed dosage of medication is delivered to the drug
delivery device and a transporting device that receives and holds more
than one drug delivery device and moves the drug delivery devices in a
controlled manner from one station to another station. The system is
configured so that two or more separate drug delivery devices can be
acted upon at the same time.

30. An automated system for use in the preparation of medication orders,
comprising: at least one database configured for storing: a plurality of
medication orders; and, identifying information for each of a plurality
of medication sources; a computer controller, in communication with said
at least one database, wherein for preparation of each given order of
said plurality of medication orders said computer controller is
configured to: access automatically said identifying information for at
least one of said plurality of medication sources corresponding with said
given order; and, compare automatically identifying information read from
a corresponding selected medication source to said identifying
information for said at least one of said plurality of medication sources
corresponding with said given order; and, a camera to obtain an image of
the corresponding selected medication source.

31. An automated system as recited in claim 30, wherein for each given
order of said plurality of medication orders said computer controller is
configurable to: identify automatically said at least one of said
plurality of medication sources corresponding with the given order for
use in preparation of the given order.

32. An automated system as recited in claim 30, further comprising: a
reader, in communication with said computer controller, wherein for each
given order of said plurality of medication orders said reader is
operable to: read said identifying information from said corresponding
selected medication source.

33. An automated system as recited in claim 32, wherein for a given order
of said plurality of medication orders the automated system is operable
to identify automatically whether the corresponding selected medication
source is for multi-use.

34. An automated system as recited in claim 32, said reader comprising: a
bar code scanner.

35. An automated system as recited in claim 30, further comprising: at
least one scale, in communication with said computer controller, wherein
for each given order of said plurality of medication orders said at least
one scale is operable to: measure a corresponding weight of the
corresponding selected medication source, wherein said corresponding
weight is stored in the system.

36. An automated system as recited in claim 34, wherein said at least one
scale comprises: a load cell; and, a platform on the load cell for
placement of each selected medication source thereupon.

37. An automated system as recited in claim 30, further comprising: a
label printer, in communication with said computer controller, wherein
for each given order of said plurality of medication orders said label
printer is operable to: print a corresponding label for application to a
corresponding delivery device for containing medication corresponding
with the given order of said plurality of medication orders.

38. An automated system as recited in claim 37, wherein for each given
order of said plurality of medication orders said corresponding label
identifies said medication corresponding with the given order of said
plurality of medication orders.

39. An automated system as recited in claim 38, further comprising: a
reader, in communication with said computer controller, wherein for each
given order of said plurality of medication orders said reader is
operable to: read said corresponding label applied to said corresponding
delivery device to confirm that the corresponding label properly
identifies said medication corresponding with the given order of said
plurality of medication orders.

40. An automated system as recited in claim 37, further comprising: at
least one scale, in communication with said computer controller, wherein
for each given order of said plurality of medication orders said at least
one scale is operable to: measure a corresponding weight of said
corresponding delivery device after delivery of said medication
corresponding with the given order of said plurality of medication orders
in to the corresponding delivery device.

41. An automated system as recited in claim 40, wherein for each given
order of said plurality of medication orders said automated system is
operable to: Compare automatically said corresponding weight of said
corresponding delivery device to a corresponding stored value to
determine if the weight of said corresponding delivery device is within a
range of acceptable values.

42. An automated system as recited in claim 37, wherein for each given
order of said plurality of medication orders said corresponding delivery
device is one of: a syringe; and, a bag; and, wherein each of said
plurality of medication sources is one of: a vial containing a
medication; and, a bag containing a fluid medication.

43. An automated system as recited in claim 42, wherein for each given
order of said plurality of medication orders said computer controller is
operable to: control automated delivery of said medication corresponding
with the given order of said plurality of medication orders to said
corresponding delivery device.

44. An automated system as recited in claim 42, further comprising: a
plurality of valves, in communication with said computer controller,
wherein for a given order of said plurality of medication orders said
plurality of valves are operable to: selectively control fluid
interconnection between each of a selected plurality of said plurality of
medication sources and a common line in fluid communication with the
corresponding delivery device.

45. An automated system as recited in claim 44, wherein for a given order
of said plurality of medication orders said plurality of valves are
operable to: selectively control fluid interconnection between at least
one diluent source and said common line in fluid communication with the
corresponding delivery device.

46. An automated system as recited in claim 30, further comprising: a
computer display, wherein for each given order of said plurality of
medication orders said computer display is operable for a user to track
the corresponding drug delivery device in the system.

47. An automated system as recited in claim 30, further comprising: an
input in communication with said computer controller, wherein for each
given order of said plurality of medication orders said input is operable
to: receive user input data that includes medication source information
corresponding with the given order.

48. An automated system as recited in claim 30, said at least one
database further configured for storing: reconstitution instructions
corresponding with each of a plurality of reconstitutable medications
comprising said plurality of medication sources; wherein for a given
order of said plurality of medication orders said computer controller is
configurable to: access automatically said reconstitution instructions
for at least one of said plurality of reconstitutable medications
corresponding with the given order for use in preparation of the given
order.

49. An automated system as recited in claim 30, further comprising: a
label printer, in communication with said computer controller, wherein
for each given order of said plurality of medication orders said label
printer is operable to: print a corresponding label for application to a
corresponding delivery device for containing medication corresponding
with the given order of said plurality of medication orders; and, at
least one scale, in communication with said computer controller, wherein
for each given order of said plurality of medication orders said at least
one scale is operable to: measure a corresponding weight of said
corresponding delivery device after delivery of said medication
corresponding with the given order of said plurality of medication orders
in to the corresponding delivery device.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation of U.S. patent application Ser.
No. 14/192,623, filed Feb. 27, 2014, which is a continuation of U.S.
patent application Ser. No. 13/545,227, filed Jul. 10, 2012, now U.S.
Pat. No. 8,678,047, issued Mar. 25, 2014, which is a continuation of U.S.
patent application Ser. No. 12/717,488, filed Mar. 4, 2010, now U.S. Pat.
No. 8,220,503, issued Jul. 17, 2012, which is a continuation of U.S.
patent application Ser. No. 11/555,577, filed Nov. 1, 2006, now U.S. Pat.
No. 7,753,085, issued Jul. 13, 2010, which is a continuation-in-part of
U.S. patent application Ser. No. 11/434,850, filed May 15, 2006, now U.S.
Pat. No. 7,240,699, issued Jul. 10, 2007, which is a continuation of U.S.
patent application Ser. No. 10/728,371, filed Dec. 3, 2003, now U.S. Pat.
No. 7,117,902, issued Oct. 10, 2006, which claims the benefit of U.S.
Patent Application No. 60/430,481, filed Dec. 3, 2002, and U.S. Patent
Application No. 60/470,328, filed May 13, 2003, each of which foregoing
applications are hereby incorporated by reference in their entirety.

TECHNICAL FIELD

[0002] The present invention relates generally to medical and
pharmaceutical equipment, and more particularly, to an automated system
for preparing a drug delivery device, such as a syringe, to receive a
unit dose of medication and then dispensing the unit dose of medication
into the drug delivery device (e.g., a syringe) and to a number of safety
and control features that preserve the integrity and optimize the
performance and capabilities of the system.

BACKGROUND

[0003] Disposable syringes are in widespread use for a number of different
types of applications. For example, syringes are used not only to
withdraw a fluid (e.g., blood) from a patient but also to administer a
medication to a patient. In the latter, a cap or the like is removed from
the syringe and a unit dose of the medication is carefully measured and
then injected or otherwise disposed within the syringe.

[0004] As technology advances, more and more sophisticated, automated
systems are being developed for preparing and delivering medications by
integrating a number of different stations, with one or more specific
tasks being performed at each station. For example, one type of exemplary
automated system operates as a syringe filling apparatus that receives
user inputted information, such as the type of medication, the volume of
the medication and any mixing instructions, etc. The system then uses
this inputted information to disperse the correct medication into the
syringe up to the inputted volume.

[0005] In some instances, the medication that is to be delivered to the
patient includes more than one pharmaceutical substance. For example, the
medication can be a mixture of several components, such as several
pharmaceutical substances.

[0006] By automating the medication preparation process, increased
production and efficiency are achieved and better environmental control
of the production process is achieved, thereby reducing opportunities for
contamination. This results in reduced production costs and also permits
the system to operate over any time period of a given day with only
limited operator intervention for manual inspection to ensure proper
operation is being achieved. Such a system finds particular utility in
settings, such as large hospitals, where a large number of doses of
medications that must be prepared daily. Traditionally, these doses have
been prepared manually in what is an exacting but tedious responsibility
for a highly skilled staff. In order to be valuable, automated systems
must maintain the exacting standards set by medical regulatory
organizations, while at the same time simplifying the overall process and
reducing the time necessary for preparing the medications.

[0007] Because syringes are used often as the carrier means for
transporting and delivering the medication to the patient, it is
advantageous for these automated systems to be tailored to accept
syringes. However, the previous methods of dispersing the medication from
the vial and into the syringe were very time consuming and labor
intensive. More specifically, medications and the like are typically
stored in a vial that is sealed with a safety cap or the like. In
conventional medication preparation, a trained person retrieves the
correct vial from a storage cabinet or the like, confirms the contents
and then removes the safety cap manually. This is typically done by
simply popping the safety cap off with one's hands. Once the safety cap
is removed, the trained person inspects the integrity of the membrane and
cleans the membrane. An instrument, e.g., a needle, is then used to
pierce the membrane and withdraw the medication contained in the vial.
The withdrawn medication is then placed into a syringe to permit
subsequent administration of the medication from the syringe.

[0008] All injections must be administered as liquids. If an injectable
substance has a limited shelf-life as a liquid, it may be provided in
solid or powdered for to be liquefied with a diluent, such as water or
saline, prior to use. The process is called reconstitution and involves
selecting an appropriate diluent, injecting the measured volume of
diluent into the vial, and agitating the vial to ensure complete
dissolution of the drug. The medication thus initially comes in a solid
form and is contained in an injectable drug vial and then the proper
amount of diluent is added and the vial is agitated to ensure that all of
the solid goes into solution, thereby providing a medication having the
desired concentration. The drug vial is typically stored in a drug
cabinet or the like and is then delivered to other stations where it is
processed to receive the diluent. This is a time consuming process and is
open to human error in the reconstitution of the medication.

[0009] What is needed in the art and has heretofore not been available is
a system and method for automating the medication preparation process and
more specifically, an automated system and method for preparing a syringe
including preparing and filling the syringe with reconstituted
medication, as well as a number of safety features that improve the
integrity of the process.

SUMMARY

[0010] An automated medication preparation system for preparing a
prescribed dosage of medication in a drug delivery device includes a
plurality of stations for receiving, handling and processing the drug
delivery device so that the prescribed dosage of medication is delivered
to the drug delivery device and a transporting device that receives and
holds more than one drug delivery device and moves the drug delivery
devices in a controlled manner from one station to another station. The
system is configured so that two or more separate drug delivery devices
can be acted upon at the same time.

[0011] In another aspect, an automated drug preparation system for
preparing a prescribed dosage of medication in a syringe includes a first
drug delivery station that includes a first automated drug delivery
device that is in fluid communication with a source of a first fluid that
is for delivery to the syringe. The system further includes an adjustable
plunger extension mechanism that includes a movable component that
intimately engages a plunger of the syringe so that a first movement of
the movable component is translated into a first extension of the plunger
a first defined distance which causes a first volume of the first fluid
to be drawn into the syringe.

[0012] The system also includes a controller that includes stored
medication orders including a final volume and concentration of the
prescribed dosage of medication, wherein and based on the stored
medication orders, the controller calculates the first defined distance
that the plunger is moved to draw the first volume of the first fluid and
causes the plunger to extend the first defined distance. When the first
volume is less than the final volume, the controller calculates the
difference between the final volume and the first volume and disengages
the fluid communication between the source of the first fluid and the
first automated drug delivery device and then calculates a second defined
distance the plunger is to be moved to permit reception of a second
volume of a second fluid and causes the plunger to extend the second
defined distance. The sum of the first and second volumes is equal to the
final volume.

[0013] In another embodiment, a method for processing a drug order and
preparing a diluted child drug product from a parent drug product, when
it is required, includes the steps of: (a) receiving and processing the
drug order and determining whether a diluted child drug product is
required as is the case when the drug order can not be prepared by
processing the parent drug product; (b) determining whether a diluted
parent drug product exists and if none exists, then determining whether
an amount of reconstituted parent drug product can be aspirated into a
syringe and an amount of diluent directly added to the syringe to yield
the diluted child drug product; and if so, then performing these
operations; and (c) if the diluted parent drug product exists, then
determining whether an amount of the diluted parent drug product can be
aspirated into a syringe and an amount of diluent directly added to the
syringe to yield the diluted child drug product; and if so, then
performing these operations; and if the diluted parent drug product does
not exist, then the parent drug product is located and an amount of the
parent drug product is aspirated into an empty container and an amount of
diluent is added to the container which is then manipulated to produce
the child drug product.

[0014] In another aspect, a method of preparing a diluted dosage of
medication with an automated drug preparation system includes the steps
of: (a) reconstituting medication in a first vial, in an automated
manner, to produce reconstituted medication have a first concentration
which is greater than an inputted target concentration of the dosage of
medication; (b) loading a syringe onto a device that controllably
delivers the loaded syringe from one station to another station; (c)
fluidly connecting the syringe to a source of diluent; (d) extending a
plunger of the syringe a predetermined distance to draw a first volume of
the diluent into the syringe; and (e) advancing the partially filled
syringe to another station where a predetermined amount of the
reconstituted medication is delivered to the partially filled syringe to
produce the dosage of medication that has a concentration at least about
equal to the inputted target concentration, wherein the reconstituted
medication is delivered to the partially filled syringe in a manner
different than drawing fluid by extension of the syringe plunger.

[0015] In yet another embodiment, a method of withdrawing a precise amount
of drug from a drug vial in an automated manner includes the steps of:
(a) identifying the type of drug vial being used; (b) accessing a
database to retrieve stored vial characteristics that are associated with
the identified drug vial; (c) positioning a vented cannula relative to
the drug vial based on the stored vial characteristics such that in a
first mode of operation, a vent port of the vented cannula is open and
the drug vial is vented to atmosphere and in a second mode of operation,
the vent port is closed; and (d) drawing the precise amount of drug from
the drug vial.

[0016] Further aspects and features of the exemplary automated drug
reconstitution system and method disclosed herein can be appreciated from
the appended Figures and accompanying written description.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] FIG. 1 is a perspective view of a housing that contains an
automated drug delivery system that prepares a dosage of medication to be
administered to a patient;

[0018] FIG. 2 is a diagrammatic plan view of the automated system for
preparing a medication to be administered to a patient;

[0019] FIG. 3 is a local perspective view of an automated device for
removing or replacing the safety tip cap from the syringe;

[0020] FIG. 4 is a local perspective view of a device for extending a
plunger of the syringe;

[0021] FIG. 5 is a local perspective view of fluid transfer and vial
preparation equipment in a fluid transfer area of the automated system;

[0022] FIG. 6 is a local perspective view of first and second fluid
delivery devices that form a part of the system of FIG. 2;

[0023] FIG. 7 is a cross-sectional view of a syringe being held with a
plunger thereof being extended by an automated plunger extension
mechanism;

[0024] FIG. 8 is a local perspective view of a multi-use vial holding
station and a vial weigh station;

[0025] FIG. 9 is a partial perspective view of a robotic device holding a
syringe and a weigh station for weighing a filled syringe;

[0026] FIG. 10 is a top plan view of a drug vial;

[0027] FIG. 11 is a cross-sectional view of a drug vial with a vented
cannula in a first position where the vent is inactive;

[0028] FIG. 12 is a cross-sectional view of a drug vial with the vented
cannula in a second position where the vent is active;

[0029] FIG. 13 is a computer screen image of the system of FIG. 2 with
indicia representing loaded stations and empty station and active and
inactive stations;

[0030] FIG. 14 is a cross-sectional view of drug delivery directly from a
drug vial by extending the plunger of a syringe with an automated
mechanism;

[0031] FIG. 15 is a flow chart illustrating the steps of a serial dilution
performed by the devices of FIG. 6;

[0032] FIG. 16 is a computer screen image of an input page for entering
information related to a drug dilution order;

[0033] FIG. 17 is a graph of the data obtained by a load cell for
determining a weight of the contents of the vial to ensure proper
reconstitution of the medication; and

[0034] FIG. 18 is a perspective view of a vibratory vial reconstitution
system for holding and mixing a drug vial.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0035] FIG. 1 is perspective view of a housing 1300 that is constructed to
house an automated drug preparation and delivery system 100 in a sealed,
controlled environment when the housing structure is closed (sealed). A
user interface, such as a computer, 1303 is provided to permit an
operator not only to enter information, such as drug orders, but also to
monitor the progress and operation of the system 100. The housing 1300
and its components are described in greater detail below.

[0036] FIG. 2 is a schematic diagram illustrating one exemplary automated
system, generally indicated at 100, for the preparation of a medication.
The automated system 100 is divided into a number of stations where a
specific task is performed based on the automated system 100 receiving
user input instructions, processing these instructions and then preparing
unit doses of one or more medications in accordance with the
instructions. The automated system 100 includes a station 110 where
medications and other substances used in the preparation process are
stored. As used herein, the term "medication" refers to a medicinal
preparation for administration to a patient. Often, the medication is
initially stored as a solid, e.g., a powder, to which a diluent is added
to form a medicinal composition. Thus, the station 110 functions as a
storage unit for storing one or medications, etc., under proper storage
conditions. Typically, medications and the like are stored in sealed
containers, such as vials, that are labeled to clearly indicate the
contents of each vial. The vials are typically stored in columns and
further, empty vials can be stored in one column. The station 110
includes a mechanism that permits the controlled discharge of a selected
drug vial 60.

[0037] A first station 120 is a syringe storage station that houses and
stores a number of syringes. For example, up to 500 syringes or more can
be disposed in the first station 120 for storage and later use. The first
station 120 can be in the form of a bin or the like or any other type of
structure than can hold a number of syringes. In one exemplary
embodiment, the syringes are provided as a bandolier structure that
permits the syringes to be fed into the other components of the system
100 using standard delivery techniques, such as a conveyor belt, etc.

[0038] The system 100 also includes an apparatus 130 for advancing the fed
syringes from and to various stations of the system 100. The apparatus
130 can be a rotary device, as shown, or it can be a linear apparatus, or
it can assume some other shape. For purposes of illustration only, the
apparatus 130 is discussed and shown as being a rotary device; however,
it is not limited to such a configuration and therefore, the present
disclosure is not limiting of the scope of the present invention.

[0039] A number of the stations are arranged circumferentially around the
rotary apparatus 130 so that the syringe is first loaded at the first
station 120 and then rotated a predetermined distance to a next station,
etc., as the medication preparation process advances. At each station, a
different operation is performed with the end result being that a unit
dose of medication is disposed within the syringe that is then ready to
be administered.

[0040] One exemplary type of rotary apparatus 130 is a multiple station
cam-indexing dial that is adapted to perform material handling
operations. The indexer is configured to have multiple stations
positioned thereabout with individual nests for each station position.
One syringe is held within one nest using any number of suitable
techniques, including opposing spring-loaded fingers that act to clamp
the syringe in its respective nest. The indexer permits the rotary
apparatus 130 to be advanced at specific intervals.

[0041] At a second station 140, the syringes are loaded into one of the
nests or the like of the rotary apparatus 130. One syringe is loaded into
one nest of the rotary apparatus 130 in which the syringe is securely
held in place. The system 100 preferably includes additional mechanisms
for preparing the syringe for use, such as removing a tip cap and
extending a plunger of the syringe at a third station 150 as described
below. At this point, the syringe is ready for use.

[0042] The system 100 also preferably includes a reader 151 that is
capable of reading a label disposed on the sealed container containing
the medication. The label is read using any number of suitable
reader/scanner/camera devices 151, such as a bar code reader, etc., so as
to confirm that the proper medication has been selected from the storage
unit of the station 110. Multiple readers can be employed in the system
at various locations to confirm the accuracy of the entire process. Once
the system 100 confirms that the sealed container (drug vial 60) that has
been selected contains the proper medication, the vial 60 is delivered to
a station 550 using an automated mechanism, such a robotic gripping
device, as will be described in greater detail. At the station 550, the
vial 60 is prepared by removing the safety cap from the sealed container
and then cleaning the exposed end of the vial. Preferably, the safety cap
is removed on a deck of the automated system 100 having a controlled
environment. In this manner, the safety cap is removed just-in-time for
use. Exemplary vial cap removal devices are disclosed in U.S. Pat. No.
6,604,903, which is hereby expressly incorporated by reference in its
entirety. In addition, the vial cap can be removed by other devices, such
as one which has a member with suction (vacuum) capabilities incorporated
therein for removing the cap. In this embodiment, the suction member is
applied to the vial cap and then the suction is activated and then the
robotic arm that is gripping and hold the vial body itself is twisted
while the drug vial cap is under suction, thus prying the cap from its
seal. The cap is still held by suction on the member until the suction is
released at which time the cap falls into a trash bin.

[0043] The system 100 also preferably includes a fourth station (fluid
transfer station) 170 for injecting or delivering a diluent into the
medication contained in the sealed container and then subsequently mixing
the medication and the diluent to form the medication composition that is
to be disposed into the prepared syringe. Alternatively, the station 170
can controllably deliver a predetermined dosage of pre-made medication.
At this fluid transfer station 170, the prepared medication composition
is withdrawn from the container (i.e., vial) and is then delivered into
the syringe. For example, a cannula can be inserted into the sealed vial
and the medication composition then aspirated into a cannula set. The
cannula is then withdrawn from the vial and is then rotated relative to
the rotary apparatus 130 so that it is in line with (above, below, etc.)
the syringe. The unit dose of the medication composition is then
delivered to the syringe, as well as additional diluent, if necessary or
desired. This is referred to as a vial mode of operation where
reconstitution of a drug is performed. The tip cap is then placed back on
the syringe at a station 180. A station 190 prints and station 195
applies a label to the syringe and a device, such as a reader, can be
used to verify that this label is placed in a correct location and the
printing thereon is readable. Also, the reader can confirm that the label
properly identifies the medication composition that is contained in the
syringe and thus performs a safety check. The syringe is then unloaded
from the rotary apparatus 130 at an unloading station 200 and delivered
to a predetermined location, such as a new order bin, a conveyor, a
sorting device, or a reject bin. The delivery of the syringe can be
accomplished using a standard conveyor or other type of apparatus. If the
syringe is provided as a part of the previously-mentioned syringe
bandolier, the bandolier is cut prior at a station 198 located prior to
the unloading station 200.

[0044] It will be appreciated that an initial labeling station 153 prior
to the drug delivery station 170 (e.g., a station right after the load
station 120) can be provided for applying a label with a unique
identifier, such as a barcode, that uniquely identifies the syringe so
that it can be tracked at any location as it is advanced from one station
to another station. In other words, a reader 155 downstream of the
initial labeling station 153 reads the unique identifier and associates
the unique identifier with this particular syringe 10. This permits each
drug order to be assigned one particular uniquely identified syringe
which is logged into and tracked by the computer. As the syringe is
advanced, its location can be tracked by the unique identifier.

[0045] A robotic device is provided for moving objects relative to the
transporter device (dial 130) and in particular, the robotic device can
deliver and/or remove objects, such as the syringe 10 or the drug vials
60, relative to the dial 130. The robotic device thus typically has a
gripper mechanism, such as a pair of grippers, for grasping and holding
the object.

[0046] FIGS. 2-5 illustrate parts of the third station 150 for preparing a
syringe 10, the fluid transfer station 170, and the station 180 for
preparing the syringe for later use. As is known, a conventional syringe
10 includes a barrel 20 into which fluid is injected and contained and at
a barrel tip, a cap 40 is provided to close off the barrel 20. A plunger
50 is slidingly received within the barrel 20 for both drawing fluid into
the barrel and discharging fluid therefrom.

[0047] FIGS. 2-5 thus illustrate in more detail the stations and automated
devices that are used in removal of the tip cap 40 from the barrel tip,
the filling of barrel chamber with medication and the replacement of the
tip cap 40 on the barrel tip. FIG. 3 is a perspective view of an
automated device 300 at station 150 that removes the tip cap 40 from the
barrel tip as the syringe 10 is prepared for receiving a prescribed dose
of medication at station 170 of the automated medication preparation
system 100. The device 300 is a controllable device that is operatively
connected to a control unit, such as a computer, which drives the device
300 to specific locations at selected times. The control unit can be a
personal computer that runs one or more programs to ensure coordinated
operation of all of the components of the system 100. The device 300 and
other suitable devices described in greater detail in U.S. Ser. No.
10/426,910, which is hereby incorporated by reference in its entirety.

[0048] As previously mentioned, one exemplary rotary device 130 is a
multiple station cam-indexing dial that is adapted to perform material
handling operations. The dial 130 has an upper surface 132 and means 134
for securely holding one syringe 10 in a releasable manner and in a
spaced relationship. Exemplary means 134 is disclosed in U.S. Pat. No.
6,915,823, which is incorporated herein by reference in its entirety.

[0049] A post 161 is provided for holding the tip cap 40 after its removal
to permit the chamber to be filled with medication. The post 161 can also
be formed on the upper surface 132 of the dial 130. Thus, the precise
location of the post 161 can vary so long as the post 161 is located
where the tip cap 40 can sit without interfering with the operation of
any of the automated devices and also the post 161 should not be
unnecessarily too far away from the held syringe 10 since it is desired
for the automated devices to travel a minimum distance during their
operation to improve the overall efficiency of the system 100. The
specific shape of the post 161 can likewise vary so long as the post 161
can hold the tip cap 40 so that it remains on the post 161 during the
rotation of the dial 130 as the associated syringe 10 is advanced from
one station to another station.

[0050] While in one exemplary embodiment, the syringes 10 are fed to the
rotary device 130 as part of a syringe bandolier (i.e., multiple syringes
10 are disposed in series and interconnected by a web), it will be
appreciated that the syringes 10 can be fed to the rotary device 130 in
any number of other ways. For example, the syringes 10 can be fed
individually into and held individually on the rotary device 130 from a
loose supply of syringes 10.

[0051] The automated device 300 is a robotic device and preferably, the
automated device 300 is a linear actuator with a gripper. For example,
the device 300 has first and second positionable gripping arms 340, 350
which are adjustable in at least one direction and which are coupled to
and extend downwardly from the block member 330. For example, each of the
gripping arms 340, 350 is movable at least in a direction along the y
axis which provide the flexibility and motion control that is desirable
in the present system 100. The gripping arms 340, 350 are programmed to
work together in tandem so that both arms 340, 350 are driven to the same
location and the same time. This permits an object, such as the cap 40,
to be held and moved to a target holding location.

[0052] The precise movements of the gripper device 300 are described in
the '910 application. In general, the gripper device 300 can be any
robotic device that can hold and move an object, such as the tip cap 40,
from one location to another location.

[0053] Now referring to FIG. 4, the system 100 also includes a device 400
for extending the plunger 50 of one uncapped syringe 10 after it has had
its tip cap 40 removed therefrom. For ease of illustration, the device
400, as well as the device 300, are described as being part of the third
station 150 of the system 100. The device 400 extends the plunger 50 so
that the syringe 10 can receive a desired dose based upon the particular
syringe 10 being used and the type of application (e.g., patient's needs)
that the syringe 10 is to be used for. The device 400 can have any number
of configurations so long as it contains a feature that is designed to
make contact with and withdraw the plunger 50. In one exemplary
embodiment, the automated device 400 is a robotic device and preferably,
the automated device 400 is a linear actuator with a gripper. For
example, one exemplary device 400 is a mechanical device that has a
movable gripper 410 that includes a gripping edge 420 that engages the
flange 54 of the plunger 50, as shown in FIG. 4, and then the gripper 410
is moved in a downward direction causing the plunger 50 to be moved a
predetermined amount. For example, the gripper 410 can be the part of an
extendable/retractable arm that includes the gripping edge 420 for
engaging the syringe 10 above the plunger flange 54. When an actuator or
the like (e.g., stepper motor) causes the gripper 410 to move in a
downward direction, the gripping edge 420 seats against the flange 54 and
further movement of the gripper 410 causes the extension of the plunger
50. Once the plunger 50 has been extended the prescribed precise
distance, the gripper 410 moves laterally away from the plunger 50 so
that the interference between the flange 54 of the plunger 50 and the
gripping edge 420 no longer exits. In other words, the gripper 410 is
free of engagement with the plunger 50 and can therefore be positioned
back into its initial position by being moved laterally and/or in an
up/down direction (e.g., the gripper 410 can move upward to its initial
position). An exemplary plunger extending device is described in commonly
assigned U.S. patent application Ser. No. 10/457,066, which is hereby
incorporated by reference in its entirety.

[0054] Thus, the device 400 complements the device 300 in getting the
syringe 10 ready for the fluid transfer station at which time, a
prescribed amount of medication or other medication is dispensed into the
chamber 30 of the barrel 20 as will be described in greater detail
hereinafter.

[0055] Of course, it will be appreciated that the syringes 10 can be
provided without caps 40 and thus, the device 300 is not needed to remove
caps 40 if the syringes 10 are loaded onto dial 130 without caps 40.

[0056] The device 400 is part of the overall programmable system and
therefore, the distance that the gripper 410 moves corresponds to a
prescribed movement of the plunger 50 and a corresponding increase in the
available volume of the chamber of the barrel 20. For example, if the
prescribed unit dose for a particular syringe 10 is 8 ml, then the
controller instructs the device 400 to move the gripper 410 a
predetermined distance that corresponds with the plunger 50 moving the
necessary distance so that the volume of the barrel chamber is at least 8
ml. This permits the unit dose of 8 ml to be delivered into the barrel
chamber. As described below, the device 400 can be operated multiple
times with reference to one syringe 10 in that the plunger 50 can be
extended a first distance during a first operation of the device 400 and
a second distance during a subsequent second operation of the device 400.

[0057] In one example, after the syringe 10 has been prepared by removing
the tip cap 40 and extending the plunger 50 a prescribed distance, the
syringe 10 is then delivered to the fluid transfer station 170 where a
fluid transfer device 500 prepares and delivers the desired amount of
medication.

[0058] Now turning to FIG. 5 in which a drug preparation area is
illustrated in greater detail to show the individual components thereof.
More specifically, a drug transfer area for the vial mode of operation of
the system 100 is illustrated and is located proximate the rotary dial
130 so that after one drug vial 60 is prepared (reconstituted), the
contents thereof can be easily delivered to one or more syringes 10 that
are securely held in nested fashion on the rotary dial 130. As previously
mentioned, drug vials 60 are stored typically in the storage cabinet 110
and can be in either liquid form or solid form or even be empty. A driven
member, such as a conveyor belt 111, delivers the drug vial 60 from the
cabinet 110 to a first robotic device (e.g., a pivotable vial gripper
mechanism) 510 that receives the vial 60 in a horizontal position and
after gripping the vial with arms (grippers) or the like, the mechanism
510 is operated so that the vial 60 is moved to a vertical position
relative to the ground and is held in an upright manner.

[0059] The mechanism 510 is designed to deliver the vial 60 to a rotatable
pedestal 520 that receives the vial 60 once the grippers of the mechanism
510 are released. The vial 60 sits upright on the pedestal 520 near one
edge thereof that faces the mechanism 510 and is then rotated so that the
vial 60 is moved toward the other side of the pedestal 520. It will be
understood that any number of different robotic mechanisms can be used to
handle, move and hold the vial.

[0060] As the pedestal rotates, the vial 60 is scanned as by a barcode
reader 151 or the like and preferably a photoimage thereof is taken and
the vial 60 is identified. If the vial 60 is not the correct vial, then
the vial 60 is not used and is discarded using a gripper device that can
capture and remove the vial 60 from the pedestal before it is delivered
to the next processing station. The central control has a database that
stores all the identifying information for the vials 60 and therefore,
when a dose is being prepared, the controller knows which vial (by its
identifying information) is to be delivered from the cabinet 110 to the
pedestal 520. If the scanning process and other safety features does not
result in a clear positive identification of the vial as compared to the
stored identifying information, then the vial is automatically discarded
(e.g., returned to a further inspection station) and the controller will
instruct the system to start over and retrieve a new vial.

[0061] The reader, such as a scanner, 151 can also read the vial 60 to
ensure that the proper vial 60 has been delivered and gripped by the
robotic device. This is another safety check and can be implemented with
barcodes or the like. The reader 151 initially reads the barcode or other
identifying information contained on the vial 60 and this read
information is compared to a stored database that contains the inputted
drug information. If the product identification information does not
match, the operator is notified and the vial 60 is not advanced to the
next station.

[0062] If the vial 60 is identified as being the correct vial, then a vial
gripper device (robotic device) 530 moves over to the pedestal for
retrieving the vial 60 (alternatively, this robotic device can be the
same robotic device that delivers the vial 60 to the pedestal). The vial
gripper device 530 is configured to securely grip and carry the vial in a
nested manner to the next stations as the drug is prepared for use.
Details and operation of the vial gripper device 530 are described in
detail in U.S. patent application Ser. No. 11/434,850, which is hereby
incorporated by reference in its entirety. The robotic device 530
includes a pair of grippers or arms 539 (gripper unit) that are
positionable between closed and open positions with the vial 60 being
captured between the arms in the closed position in such a manner that
the vial 60 can be securely moved and even inverted and shaken without
concern that the vial 60 will become dislodged and fall from the arms.
The arms thus have a complementary shape as the vial 60 so that when the
arms close, they engage the vial and nest around a portion (e.g., neck
portion) of the vial 60 resulting in the vial 60 being securely captured
between the arms. As with some of the other components, the arms can be
pneumatically operated arms or some other mechanical devices.

[0063] In order to retrieve the vial 60 from the pedestal 520, the device
530 is driven forward and then to one side so that it is position
proximate the pedestal 520. The gripper unit 539 is then moved downward
so that the arms, in their open position, are spaced apart with the vial
60 being located between the open arms. The gripper unit 539 is then
actuated so that the arms close and capture the vial 60 between the arms.
Next the robotic device 530 is moved upward and the device 530 is driven
back to the opposite side so as to introduce the vial 60 to the next
station. The vial 60 is also inverted by inversion of the gripper unit
539 so that the vial 60 is disposed upside down.

[0064] The inverted vial 60 is then delivered to a station 550 where the
vial 60 is prepared by removing the safety cap from vial 60. This station
550 can therefore be called a vial decapper station. Any number of
devices can be used at station 550 to remove the safety cap from the
vial. For example, several exemplary decapper devices are disclosed in
commonly-assigned U.S. Pat. No. 6,604,903 which is hereby incorporated by
reference in its entirety. After the vial 60 is decapped, the vial is
then delivered, still in the inverted position, to a cleaning station 560
where the exposed end of the vial is cleaned. For example, underneath the
removed vial safety cap, there is a septum that can be pierced to gain
access to the contents of the vial. The cleaning station 560 can be in
the form of a swab station that has a wick saturated with a cleaning
solution, such as an alcohol. The exposed area of the vial 60 is cleaned
by making several passes over the saturated wick which contacts and baths
the exposed area with cleaning solution. After the vial 60 is cleaned at
the station 560, the gripper unit 539 rotates so that the vial 60 is
returned to its upright position and remains held between the gripper
arms.

[0065] The vial 60 can then be delivered to a weigh station 540 (FIG. 8)
where the weight of the vial with solid medication (or an empty vial or
any other object) is measured and stored in the computer system. Any
number of different devices, such as scales, can be used to weigh the
vial; however, one exemplary device for weighing the vial 60 and any
other object for that matter, is a load cell 542. Load cell 542 is a
transducer for the measurement of force or weight, usually based on a
strain gauge bridge or vibrating wire sensor. In particular and as shown
in FIG. 8, the load cell 542 includes a housing or body 544 that contains
the working components and electronics of the load cell 542 and a
platform 546 on which the item, in this case, the vial, to be weighed is
placed.

[0066] The load cell 542 is part of an overall automated and integrated
system and therefore, it contains software that communicates with the
master controller so that the operation of the complete system 100 can be
controlled, including the movement of the robotic device 530 that holds
and transport the vial 60 from one location to another location. As shown
in FIG. 8, the vial 60 is held by the robotic device about the neck
portion and can therefore be delivered onto the load cell platform 546.
In one embodiment, the robotic device moves the vial 60 from the pedestal
520 to the platform 546.

[0067] The software controlling the robotic device is configured so that
the vial grippers of the robotic device are first approximately level
with the standby pedestal 520 and at this point, the software of the load
cell gathers a predetermined number, such as 10-15 (e.g., 15) weights
from the load cell 542 which are considered the tare weight. The vial 60
is then shuttled down to a predetermined distance, such as 2.5 mm, above
the load cell platform 546. From this predetermined distance (e.g., 2.5
mm), the load cell software shuttles the vial 60 down towards the load
cell platform 546 very slowly, while monitoring the weights returned by
the load cell 542 to determine the exact moment the vial makes contact
with the platform 546 (i.e., which will register a marked increase in
observed weight). At the moment the vial contact the platform, the
software instructs the vial grippers to open and all vertical movement of
the vial is stopped. A predetermined time, such as 0.5 seconds, after the
vial grippers open, the software collects a predetermined number, such as
10-15 (e.g., 15) weight measurements from the load cell, which shall be
considered the weight of the vial and the load cell platform.

[0068] The data collected by the load cell can be processed in any number
of different ways and in one embodiment, as shown in FIG. 17, a graph is
created where the x axis is the measured amplitude (AtoD counts) and the
y axis is the time (ms). The point at which the vial makes contact with
the load cell 542 is indicated at line 545. The vial weight (AtoD counts)
is equal to the measured weight-tare. The vial weight (grams) is equal to
(vial weight (AtoD counts)*slope)+intercept. In another embodiment, data
is not displayed but is manipulated inside the master controller and the
final results are used for system reaction.

[0069] As will be described below, since the initial weight of the vial is
measured and stored and later, the weight of the reconstituted drug in
the vial is calculated, a safety check can be performed to determine if
the proper drug product was fabricated.

[0070] In another embodiment, such as in a serial dilution scheme, an
empty child vial is weighed and diluent is added and weighed. After that,
drug is added to the vial with diluent and weighed. Then the system
calculates the amount of the diluent and drug added to the vial and knows
the final composition of the drug in the vial.

[0071] The device 530 then advances forward to the fluid transfer station
170 according to one embodiment. The fluid transfer station 170 is an
automated station where the medication (drug) can be processed so that it
is in a proper form for delivery (injection) into one of the syringes 10
that is coupled to the rotary dial 130. As mentioned before, the fluid
transfer station 170 is used during operation of the system, at least
partially, in a vial mode of operation. When the vial 60 contains only a
solid medication and it is necessary for a diluent (e.g., water or other
fluid) to be added to liquefy the solid, this process is called a
reconstitution process. Alternatively and as will be described in detail
below, the medication can already be prepared and therefore, in this
embodiment, the fluid transfer station is a station where a precise
amount of medication is simply aspirated or withdrawn from the vial 60
and delivered to the syringe 10.

[0072] For purpose of illustration, the reconstitution process is first
described. After having been cleaned, the vial 60 containing a prescribed
amount of solid medication is delivered in the upright position to the
fluid transfer station 170 by the device 530. As will be appreciated, the
device 530 has a wide range of movements in the x, y and z directions and
therefore, the vial 60 can easily be moved to a set fluid transfer
position. At this position, the vial 60 remains upright and a fluid
transfer device 580 is brought into position relative to the vial 60 so
that an automated fluid transfer can result therebetween. More
specifically, the fluid transfer device 580 is the main means for both
discharging a precise amount of diluent into the vial 60 to reconstitute
the medication and also for aspirating or withdrawing the reconstituted
medication from the vial 60 in a precise, prescribed amount. The device
580 is a controllable device that is operatively connected to a control
unit, such as a computer, which drives the device 580 to specific
locations at selected times and controls with a high degree of precision
the operation and discharge of medication. The control unit can be a
personal computer that runs one or more programs to ensure the
coordinated operation of all of the components of the system 100.

[0073] As illustrated in FIGS. 1 and 6, one exemplary fluid transfer
device 580 is a robotic device having a movable cannula unit 590 that can
be moved in a controlled up and down and side-side, etc., manner so to
either lower it or raise it relative to the vial 60 in the fluid transfer
position and to move it into the proper position. For example, the
cannula unit 590 can be pneumatically operated or operated by an electric
motor or some other means to cause the controlled movement of the cannula
unit 590.

[0074] At one end of the cannula unit 590, a cannula 610 is provided. The
cannula 610 has one end that serves to pierce the septum of the vial 60
and an opposite end that is connected to a main conduit 620 that serves
to both deliver diluent to the cannula 610 and ultimately to the vial 60
and receive aspirated reconstituted medication from the vial 60.
Preferably, the cannula 610 is of the type that is known as a vented
cannula which can be vented to atmosphere as a means for eliminating any
dripping or spattering of the medication during an aspiration process.
More specifically, the use of a vented needle to add (and withdraw) the
fluid to the vial overcomes a number of shortcoming associated with
cannula fluid transfer and in particular, the use of this type of needle
prevents backpressure in the vial (which can result in blow out or
spitting or spraying of the fluid through the piercing hole of the
cannula). The venting takes place via an atmospheric vent that is located
in a clean air space and is formed in a specially designed hub that is
disposed over the needle. By varying the depth that the needle penetrates
the vial, the user can control whether the vent is activated or not. It
will be appreciated that the venting action is a form of drip control
(spitting) that may otherwise take place. Drip control is a process after
aspiration where fluid is sucked back into the cannula 610 (tube) to
prevent dripping of the drug and then the cannula 610 is transferred to
the syringe for dispensing.

[0075] Moreover, the cannula 610 is also preferably of the type that is
motorized so that the tip of the cannula 610 can move around within the
vial 60 so that cannula 610 can locate and aspirate every last drop of
the medication. In other words, the cannula 610 itself is mounted within
the cannula unit 590 so that it can move slightly therein such that the
tip moves within the vial and can be brought into contact with the
medication wherever the medication may lie within the vial 60. Thus, the
cannula 610 is driven so that it can be moved at least laterally within
the vial 60.

[0076] An opposite end of the main conduit 620 is connected to a fluid
pump system 630 that provides the means for creating a negative pressure
in the main conduit 620 to cause a precise amount of fluid to be
withdrawn into the cannula 610 and the main conduit 620, as well as
creating a positive pressure in the main conduit 620 to discharge the
fluid (either diluent or medication) that is stored in the main conduit
620 proximate the cannula 610. One exemplary fluid pump system 630, as
well as the operation thereof, is described in great detail in the '823
patent, which has been incorporated by reference. The net result is that
the prescribed amount of diluent that is needed to properly reconstitute
the medication is delivered through the cannula 610 and into the vial 60.
Accordingly, the cannula 610 pierces the septum of the vial and then
delivers the diluent to the vial and the vial 60 can be inverted to cause
agitation and mixing of the contents of the vial or the vial can be
delivered to a separate mixing device to cause the desired mixing of the
contents.

[0077] After the medication in the vial 60 has been reconstituted as by
inversion of the vial and/or mixing, as described herein, the fluid pump
system 630 is then operated so that a prescribed amount of medication is
aspirated or otherwise drawn from the vial 60 through the cannula 610 and
into the main conduit 620. Before the fluid is aspirated into the main
conduit 620, an air bubble is introduced into the main conduit 620 to
serve as a buffer between the diluent contained in the conduit 620 to be
discharged into one vial and the aspirated medication that is to be
delivered and discharged into one syringe 10. It will be appreciated that
the two fluids (diluent and prepared medication) can not be allowed to
mix together in the conduit 620. The air bubble serves as an air cap in
the tubing of the cannula and serves as an air block used between the
fluid in the line (diluent) and the pulled medication. According to one
exemplary embodiment, the air block is a 1/10 ml air block; however, this
volume is merely exemplary and the size of the air block can be varied.

[0078] After aspirating the medication into the main conduit 620, the
fluid transfer device 580 is rotated as is described below to position
the cannula 610 relative to one syringe 10 that is nested within the
rotary dial 130. The pump mechanism 630 is actuated to cause the
controlled discharge of the prescribed amount (dosage) of medication
through the cannula 610.

[0079] As the pump mechanism 630 is operated, the air block continuously
moves within the main conduit 620 toward the cannula 610. When all of the
pulled (aspirated) medication is discharged, the air block is positioned
at the end of the main conduit signifying that the complete pulled
medication dose has been discharged; however, none of the diluent that is
stored within the main conduit 620 is discharged into the syringe 10
since the fluid transfer device 580, and more particularly, drivers or
the like of the system, operate with such precision that only the
prescribed medication that has been previously pulled into the main
conduit 620 is discharged into the vial 60.

[0080] It will be appreciated that the fluid transfer device 580 may need
to make several aspirations and discharges of the medication into the
vial 60 in order to inject the complete prescribed medication dosage into
the vial 60. In other words, the cannula unit 590 can operate to first
aspirate a prescribed amount of fluid into the main conduit 620 and then
is operated so that it rotates over to and above one syringe 10 on the
rotary dial 130, where one incremental dose amount is discharged into the
vial 60. After the first incremental dose amount is completely discharged
into the syringe 10, the cannula unit 590 is brought back the fluid
transfer position where the fluid transfer device is operated so that a
second incremental dose amount is aspirated into the main conduit 620 in
the manner described in detail hereinbefore. The cannula unit 590 is
brought back to the rotary dial 130 above the syringe 10 that contains
the first incremental dose amount of medication. The cannula 610 is then
lowered so that the cannula tip is placed within the interior of the
syringe 10 and the cannula unit 590 is operated so that the second
incremental dose amount is discharged into the syringe 10. The process is
repeated until the complete medication dose is transferred into the
syringe 10.

[0081] It will further be appreciated that the cannula unit 590 can be
configured so that it can be operated at varying speeds of aspiration.
For example, the software associated with the cannula unit 590 can offer
the operator a number of different aspiration programs to choose from or
the operator can program the unit 590 with a unique aspiration process or
program by entering or inputting aspiration instructions. For example,
the unit 590 can operate by first aspirating the medication at a first
speed and for a first time period and then aspirating the medication at a
second speed for a second time period. According to one embodiment, the
first speed is greater than the second speed and the first time period is
greater than the second time period; however, the opposite can be equally
true and it will further be appreciated that there may be more than 2
distinct aspiration phases. For example, there can be a first aspiration
phase that operates at a first aspiration speed, a second aspiration
phase that operates at a second speed and a third aspiration phase that
operates at a third aspiration speed. The speed of the aspiration can be
varied by simply varying the speed of the pump. In this manner, the
initial aspiration of the medication can operate at a higher speed and
then when only a small amount of medication remains, the aspiration speed
can be reduced so as to controllably withdraw the last portion of the
medication that is contained in the container.

[0082] In addition, the reconstitution equipment, including the cannula
unit 590, can possess various motions, including a gentle inversion to
"wet" the solid drug in the vial 60 with the diluent that was added to
the vial 60 and an agitation motion which causes the drug to go into
solution. The system 100, and in particular, the reconstitution module
thereof, is configured to operate in this manner since the reconstitution
process uses both motions based upon key drug characteristics. A database
controls the differences observed from drug to drug. In one embodiment,
the robotic gripper holds the drug vial 60 during the agitation cycle so
that is does not become dislodged. The associated software preferably
possesses a QA function that enables the drug to be tested under various
conditions to assure that the settings effect putting the drug into
solution, and the ability to have the reconstituted drug manually
observed, by the robotic gripper removing the drug from the
reconstitution station 170 and presenting the vial 60 to a window (when
the system 100 is contained within an enclosed structure as described
below) for an operator to look at the vial 60 and enter their
observations into a reconstitution QA database. If the drug was not fully
in solution, the entry into the QA database can be used to adjust the
formulary to require an additional increment of agitation time.

[0083] In other words, the software is designed so that once the operator
enters the drug order, the master controller accesses the reconstitution
database that includes detailed instructions as to how to prepare the
reconstituted drug of the order and part of these instructions include
instructions on the aspiration process as discussed below. In particular,
once the drug type of the order is identified, the aspiration
instructions are determined, including the number, length and
characteristics of the agitation phases and motions, and then the
controller instructs the equipment to execute these instructions.

[0084] In yet another embodiment, a prescribed dosage of medication can be
drawn from the vial 60 by mating a syringe 10 with the vial 60 as by
inserting the needle (vented cannula) of the syringe into and through the
septum of the vial 60 and then extending the plunger a predetermined,
precise distance so as to draw a precise amount dosage into the syringe
from the drug vial 60. The device and method for controlling the
extension of the plunger is described in great detail herein.

[0085] Once the syringe 10 receives the complete prescribed medication
dose, the vial 60 that is positioned at the fluid transfer position can
either be (1) discarded or (2) it can be delivered to a holding station
700 where it is cataloged and held for additional future use. More
specifically, the holding station 700 serves as a parking location where
a vial that is not completely used can be used later in the preparation
of a downstream syringe 10. In other words, the vials 60 that are stored
at the holding station 700 are labeled as multi-use medications that can
be reused. These multi-use vials 60 are fully reconstituted so that at
the time of the next use, the medication is only aspirated from the vials
60 as opposed to having to first inject diluent to reconstitute the
medication. The user can easily input into the database of the master
controller which medications are multi-use medications and thus when the
vial 60 is scanned and identified prior to being delivered to the fluid
transfer position, the vial 60 is identified and marked as a multi-use
medication and thus, once the entire medication dose transfer has been
performed, the vial gripper device 530 is instructed to deliver the vial
60 to the holding station 700. Typically, multi-use medications are those
medications that are more expensive than other medications and also are
those medications that are used in larger volumes (quantities) or are
stored in larger containers and therefore come in large volumes.

[0086] The holding station 700 is simply a location where the multi-use
vials can be easily stored. For example, the holding station 700 is
preferably a shelf or even a cabinet that contains a flat surface for
placing the vials 60. Preferably, there is a means for categorizing and
inventorying the vials 60 that are placed at the holding station 700. For
example, a grid with distinct coordinates can be created to make it easy
to determine where each vial 60 is stored within the holding station 700.

[0087] Once the device 530 has positioned the vial 60 at the proper
location of the holding station 700, the gripper unit is operated so that
the arms thereof release the vial 60 at the proper location. The device
530 then returns back to its default position where it can then next be
instructed to retrieve a new vial 60 from the pedestal 520.

[0088] If the vial 60 is not a multi-use medication, then the vial 60 at
the fluid transfer position is discarded. When this occurs, the device
530 moves such that the vial 60 is positioned over a waste chute or
receptacle and then the gripper unit is actuated to cause the vial 60 to
drop therefrom into the waste chute or receptacle. The device 530 is then
ready to go and retrieve a new vial 60 that is positioned at the pedestal
520 for purposes of either reconstituting the medication or simply
aspirating an amount of medication therefrom or a vial from the holding
station 700 can be retrieved.

[0089] As previously mentioned, during the reconstitution process, it is
often necessary or preferable to mix the medication beyond the mere
inversion of the vial and therefore, the vial 60 can be further agitated
using a mixing device or the like 710. In one embodiment, the mixing
device 710 is a vortex type mixer that has a top surface on which the
vial 60 is placed and then upon actuation of the mixer, the vial 60 is
vibrated or otherwise shaken to cause all of the solid medication to go
into solution or cause the medication to be otherwise mixed. In yet
another embodiment, the mixing device is a mechanical shaker device, such
as those that are used to hold and shake paint cans. For example, the
vial 60 can be placed on support surface of the shaker and then an
adjustable hold down bar is manipulated so that it travels towards the
vial and engages the vial at an end opposite the support surface. Once
the vial 60 is securely captured between these two members, the shaker
device is actuated resulting in the vial 60 being shaken to agitate the
medication and ensure that all of the medication properly goes into
solution. In addition, the mixing device 710 can also be configured so
that it is in the form of a robotic arm that holds the vial by means of
gripper members (fingers) and is operatively connected to a motor or the
like which serves to rapidly move the arm in a back and forth manner to
cause mixing of the medication.

[0090] In yet another embodiment, reconstitution is done using a process
commonly called "milking". In this process, diluent is added to the drug
vial to be reconstituted and with a series of "pull and push" motions of
fluid, reconstitution is achieved. In this process, a non-venting needle
is used.

[0091] FIG. 18 shows yet another device for mixing the contents of the
drug vial. In particular, FIG. 18 shows a vibratory reconstitution system
1400 that receives and holds a vial containing solid medication mixed
with diluent and is configured to be controllably actuated to cause
mixing of the diluent and solid medication. The system 1400 includes an
actuator 1410, such as a motor, and a first plate 1420 and a second plate
1430 that face one another and are constructed to receive a drug vial
therebetween in a grasped manner.

[0092] More specifically, the first plate 1420 includes a first feature
1422 and the second plate 1430 includes a second feature 1432 that face
each other and define a cavity 1440 that receives and holds the drug
vial. In the illustrated embodiment, the first plate 1420 and the second
plate 1430 each has a circular shape. The first and second plates 1420,
1430 can move in unison so as to permit the controlled mixing of the drug
vial that is captured between the plates 1420, 1430. The plates 1420,
1430 are operably coupled to the motor 1410 to allow controlled movement
of the plates 1420, 1430. It will therefore be appreciated that the motor
1410 can be a multi-speed motor or otherwise have multiple different
modes of operation to permit controlled wetting or mixing of the drug
vial. For example, in one mode, the contents of the drug vial are wetted
by causing rotation of the first and second plates 1420, 1430 to cause
the diluent in the drug vial to come into contact with the solid in the
drug vial resulting in wetting of the contents. In addition, the first
and second plates 1420, 1430 can be operated in a mixing mode in which
the plates 1420, 1430 oscillate or otherwise move (impart vibrations) to
cause a mixing of the contents of the drug vial.

[0093] It will be understood that the system 1400 is not limited to being
used with the drug vial but instead, the system 1400 can receive and hold
a syringe (drug delivery device) and therefore, function as a holding
station or parking station where the syringe is held in place until time
for delivering the syringe to a next station by means of a robotic device
or the like.

[0094] As briefly mentioned before, the entire system 100 is integrated
and automated and also utilizes a database for storing identifying data,
mixing instructions, and other information to assist in the preparation
of the medication. There are also a number of safety features and check
locations to make sure that the medication preparation is proceeding as
it should.

[0095] For example, the database includes identifying information so that
each vial 60 and syringe 10 can be carefully kept track of during each
step of the process. For example, the reader (e.g., barcode scanner or
camera) 151 and the photoimaging equipment serve to positively identify
the vial 60 that is delivered from the drug storage 110. Typically, the
user will enter one or more medication preparation orders where the
system 100 is instructed to prepare one or more syringes that contain
specific medication. Based on this entered information or on a stored
medication preparation order that is retrieved from a database, the vial
master controller determines at which location in the cabinet the correct
vial 60 is located. That vial 60 is then removed using a robotic gripper
device (not shown) and is then placed on the conveyor belt 111 and
delivered to the mechanism 510 pivots upright so that the vial 60 is
moved a vertical position relative to the ground and is held in an
upright manner and is then delivered to the rotatable pedestal 520. At
the pedestal 520, the vial 60 is scanned to attempt to positively
identify the vial 60 and if the scanned identifying information matches
the stored information, the vial 60 is permitted to proceed to the next
station. Otherwise, the vial 60 is discarded.

[0096] Once the vial 60 is confirmed to be the right vial it proceeds to
the fluid transfer position. The master controller serves to precisely
calculate how the fluid transfer operation is to be performed and then
monitors the fluid transfer operations has it is occurring. More
specifically, the master controller first determines the steps necessary
to undertake in order to perform the reconstitution operation. Most often
during a reconstitution operation, the vial 60 that is retrieved from the
drug storage 110 contains a certain amount of medication in the solid
form. In order to properly reconstitute the medication, it is necessary
to know what the desired concentration of the resulting medication is to
be since this determines how much diluent is to be added to the vial 60.
Thus, one piece of information that the user is initially asked to enter
is the concentration of the medication that is to be delivered to the
patient as well as the amount that is to be delivered. Based on the
desired concentration of the medication, the master controller is able to
calculate how much diluent is to be added to the solid medication in the
vial 60 to fully reconstitute the medication. Moreover, the database also
preferably includes instructions as to the mixing process in that the
mixing device is linked to and is in communication with the master
controller so that the time that the mixing device is operated is stored
in the database such that once the user inputs the medication that is to
be prepared and once the vial 60 is scanned and identified, the system
(master controller or CPU thereof) determines the correct of time that
the vial 60 is to be shaken to ensure that all of the medication goes
into solution.

[0097] Once the master controller determines and instructs the working
components on how the reconstitution operation should proceed, the master
controller also calculates and prepares instructions on how many distinct
fluid transfers are necessary to deliver the prescribed amount of
medication from the vial 60 to the syringe 10. In other words, the
cannula unit 590 may not be able to fully aspirate the total amount of
medication from the vial 60 in one operation and therefore, the master
controller determines how many transfer are needed and also the
appropriate volume of each aspiration so that the sum of the aspiration
amounts is equal to the amount of medication that is to be delivered to
the syringe 10. Thus when multiple aspiration/discharge steps are
required, the master controller instructs and controls the operation of
the pump mechanism so that the precise amounts of medication are
aspirated and then discharged into the syringe 10. As previously
described, the pump mechanism operates to cause the proper dose amount of
the medication to be first aspirated from the vial and then discharged
into the syringe. This process is repeated as necessary until the correct
dose amount is present in the syringe 10 in accordance with the initial
inputted instructions of the user. Yet in another embodiment, multiple
doses are aspirated from the vial and smaller doses are dispensed into
multiple syringes.

[0098] After transferring the proper precise amount of medication to one
syringe 10, the master controller instructs the rotary dial to move
forward in an indexed manner so that the next empty syringe 10 is brought
into the fluid transfer position. The cannula 610 is also preferably
cleaned after each medication dose transfer is completed so as to permit
the cannula 610 to be reused. There are a number of different techniques
that can be used to clean the cannula 610 between each medication
transfer operation. For example, the cleaning equipment and techniques
described in commonly assigned U.S. Pat. No. 6,616,771 and U.S. patent
application Ser. No. 10/457,898 (both of which are hereby incorporated by
reference in their entireties) are both suitable for use in the cleaning
of the cannula 610.

[0099] In one embodiment, the cannula 610 is rotated and positioned so
that the needle of the cannula 610 is lowered into a bath so that fluid
is expelled between the inside hubs of the syringe 10 for cleaning of the
interior components of the cannula 610. The cannula 610 is then
preferably dipped into a bath or reservoir to clean the outside of the
cannula 610. In this manner, the cannula 610 can be fully cleaned and
ready for a next use without the need for replacement of the cannula 610,
which can be quite a costly endeavor.

[0100] In yet another embodiment, a medication source, such as a bag that
is filled with liquid medication that has already been properly
reconstituted, is connected to an input portion of a peristaltic pump by
means of a first conduit section. A second conduit section is connected
to an output port of the pump and terminates in a connector. The
connector is of the type that is configured to hermetically seal with an
open barrel tip of the syringe 10 that is nested within the rotary dial
130 and is marked to receive medication. The connector typically includes
a conduit member (tubing) that is surrounded by a skirt member or the
like that mates with the outer hub of the syringe barrel. A flange or
diaphragm can be provided for hermetically sealing with the syringe
barrel (outer hub).

[0101] In commonly assigned U.S. patent Ser. No. 11/434,850 (which is
hereby incorporated by reference in its entirety), it is described how
the plunger 50 of the syringe 10 can be extended with precision to a
prescribed distance. In that application, the plunger 50 is extended to
create a precise volume in the barrel that is to receive a precise
prescribed dosage of medication that is injected therein at a downstream
location. However, it will be appreciated that the action of extending
the plunger 50 can serve more than this purpose since the extension of
the plunger 50 creates negative pressure within the syringe barrel and
thus can serve to draw a fluid therein. For example, once the connector
is sealingly mated with the open syringe tip end, the medication source
(e.g., an IV bag) is fluidly connected to the syringe 10 and thus can be
drawn into the syringe barrel by means of the extension of the plunger
50. In other words, the plunger 50 is pulled a precise distance that
results in the correct size cavity being opened up in the barrel for
receiving the fluid but also the extension of the plunger creates enough
negative pressure to cause the medication to be drawn into the syringe
barrel. This is thus an alternative means for withdrawing the proper
amount of medication from a member (in this case the source) and
transferring the desired, precise amount of medication to the syringe 10.
The operation of this alternative embodiment can be referred to as
operating the system in reservoir mode and is shown in FIG. 14. One
advantage of this embodiment is that multiple syringe drivers or the like
or some type of pump mechanism are not needed to pump the medication into
the syringe 10 but rather the drawing action is created right at the
rotary dial 130. This design is thus fairly simple; however, it is not
suitable for instances where drug reconstitution is necessary.

[0102] It will also be appreciated that the source does not have to be a
medication source in that it does not have to contain an active drug but
instead, the source can contain diluent that is to be drawn in a
prescribed volume into the syringe, especially for purposes of serial
dilution, as described below. More specifically and as illustrated in
FIGS. 1 and 6, in the reservoir mode, the fluid source can consist of a
number of drug delivery bags 750 that are already filled either premixed
medication or with only diluent that is later used to dilute medication
as described in detail below. The filled drug delivery bags (e.g., IV
bags) 750 can be hung in a select area, with each bag 750 having an
outlet conduit through which the fluid contained in the bag is drawn. It
will be appreciated that the outlet conduits associated with the drug
delivery bags 750 can be interconnected as by connecting each of the bag
outlet conduits to a common line 754 with one or more valves or the like
being used to selectively control which bag outlet line is in directly
fluid communication with the common line 754. In this manner, a number of
different medications can be hung and be ready for use and the user of
the system merely has to manipulate the valve (either manually or
automatically using a computer, etc.) to connect the selected bag 750 to
the common line 754.

[0103] The computer that operates the entire system can be in
communication with the valves to permit and to control the flow of the
prescribed desired fluid from one bag 750 to the common line 754. The
common line 754 is thus in communication at a first end with the outlet
conduit of the select bag 750 that contains the desired fluid and another
end of the common line 754 is configured to mate with a syringe inlet
port to permit the fluid in the bag 750 to be drawn into the bag by
extending the plunger 50 a predetermined distance as described above to
cause a precise, target volume of fluid to be drawn into the barrel of
the syringe 10. For example, the free end of the common line (conduit)
754 can contain a connector or adapter (e.g., a stopper element) 760 that
is configured to mate with the inlet opening (port) of the syringe barrel
in a sealed manner. Since it is the extension of the plunger 50 that
generates the means of drawing a prescribed volume of fluid into the
syringe barrel, the connection between the end of the common line (e.g.,
the connector thereof) and the syringe barrel is such that the creation
of negative pressure in the syringe barrel 20 causes the fluid to be
drawn into the barrel. In other words, it is desirable to establish a
seal or the like between the end of the common line 754 and the syringe
barrel so that negative pressure can be established and maintained in the
syringe barrel.

[0104] For purpose of illustration, the delivery of fluid from one source
during operation of the reservoir mode to one syringe 10 is performed at
the reservoir mode fluid delivery station 770 that is arranged relative
to the other stations of the system 100.

[0105] According to one embodiment, the free end of the common line 754 is
secured to a controllable, movable device 765, such as a robotic arm or
an automated arm, that can be controllably moved. In particular, the
movable device is moved vertically at least along a linear axis so as to
drive the free end of the common line 754 (the connector) into a sealed
coupling with the syringe barrel when it is driven in one direction or
when it is driven in the opposite direction, the common line disengages
from the barrel of the syringe 10 to permit the syringe to be advanced to
another station, such as the fluid transfer station 170 described above
where reconstituted drug can be delivered into a syringe 10 that was
previously injected with fluid through the common line 754 from the fluid
source when operating in reservoir mode.

[0106] It will be appreciated that the reservoir drug delivery station 770
and the fluid transfer station 170 are different stations that are
located at different locations, such as adjacent stations along the dial
130.

[0107] According to one aspect of the present invention, a serial dilution
operation can be performed by the system 100 by performing one or more
operations at the reservoir drug delivery station 770, where fluid is
delivered to a syringe from a source, such as one bag 750, and the drug
delivery station 170 where a drug can be reconstituted in a drug vial 60
before injection into a drug delivery device (syringe 10). Preferably,
the station 170 is downstream of the station 770 so that loaded syringes
10 are first processed at station 770 and then is processed at station
170. In general, serial dilution involves and provides a process by which
a commercially available injection is diluted to a lower concentration to
produce doses smaller than could otherwise be measured by the device that
prepares the medication. Pediatric hospitals often must produce doses of
injectable medications that are immeasurably small when prepared with
commercially available medications. This requires that the drug therefore
be diluted to a concentration where the required dose becomes measurable.
This can require one or more dilution steps to reach a required
concentration.

[0108] The system 100 of the present invention, along with other similar
devices, has practical measurement limitations based on its delivery
technology. For example, doses that are aspirated from a vial with a
pump, such as a Kloehn type pump, at the drug delivery station 170 can be
reliably measured down to a volume of 0.5 ml; doses delivered at the
reservoir mode drug delivery station 770 from the reservoir (bag 750) can
be accurately delivered down to a volume of approximately 2 ml with a
.+-.0.125 ml margin of error.

[0109] Since the reservoir mode is designed to batch fill a series of
identical syringes 10, reservoir mode restrictions can be overcome in the
process of preparing the reservoir itself. That is, the reservoir can be
prepared in a more dilute state, and any dilution necessary to achieve
the final concentration are performed during preparation of the reservoir
prior to mounting the reservoir (bag) within the system 100 at the
station 770.

[0110] When a syringe 10 is prepared from a vial 60, as in reconstitution
mode, at the drug delivery station 170, it is ordinarily filled from the
vial at its commercial concentration, which can be determined at the
manufacturer (because it is already a liquid) or can be determined by the
reconstitution for the vial in the formulary. If further dilution is
required, it cannot be performed in advance because doing so severely
limits the shelf of the product. It must either be diluted in the syringe
10 (this is referred to as QSing the syringe 10), or the additional
dilution must be prepared "on the fly" within the system 100. Currently,
there is a mechanism to perform additional dilution in the syringe 10,
but there is no mechanism to perform additional dilution in another vial.

[0111] The solution to the above deficiency that is achieved and provided
by the system 100 is to permit the system 100 itself to prepare a
dilution as needed. The process involves having the system 100 prepare an
injectable product by further diluting the original available product and
then using the dilution to prepare the dose. The system 100 is thus
configured to store and manipulate sterile empty vials 60 within the vial
cabinet at station 110, and to maintain knowledge of both the original
and diluted products until they are discarded or consumed.

[0112] In other words, if the manufacturer's product is available as a
fluid, of concentration X, and the dose required a concentration X/10,
the software would cause the device to aspirate 1 ml of the original drug
from the original container, deliver that 1 ml into an empty container,
and then deliver 9 ml of diluent to product a final concentration of
X/10. This presumes that the original drug solution and the diluent mix
volumetrically (e.g., that 1 ml of drug and 9 ml of diluent mix to create
a total volume of 10 ml). In practice, pediatric applications can require
dilutions of 10- to 30-fold. The requirement for the ability to perform
dilutions must accommodate the fact that not all immeasurable doses are
intended since a dose may be immeasurable because it was entered
incorrectly. Since, in at least one embodiment of the system 100, the
system 100 lacks the information necessary to determine whether a dose is
clinically appropriate for a given patient, the system 100 is configured
to permit dilution only when one is required to prepare a dose in
measurable range and there is a pre-defined dilution product that can be
prepared from a commercially available product defined for that purpose
in the formulary.

[0113] For the purpose of the present application, the term "parent vile"
refers to a vial containing a commercially available concentration of a
drug that is either supplied as a fluid from the manufacturer, or was
reconstituted according to its formulary definition within the system
100. The term "child vial" refers to a vial containing a concentration of
a drug that is not commercially available that is prepared by diluting an
aliquot from a parent vial with sufficient diluent to create a new, lower
concentration of drug.

[0114] According to one embodiment of the present invention and based on
the specifications of one system 100, preparation of the diluted product
is required if at least one syringe requires a dose volume of less than
0.5 ml from the parent drug. For example, if a syringe 10 requires a 1:10
dilution for a 2 ml dose, the 0.2 ml to be taken from the parent vial is
too small. As a result, if dilution is required, then it is preferred to
use up the dilution before using up the contents in the parent vial. This
can be accomplished by sorting the syringes within a drug in ascending
order by dose. This way, the smaller doses will force creation of the
diluted product (if required) and subsequent syringes 10 will use that
product until it is consumed.

[0115] One will appreciate that there is a parent-child relationship
between the diluted product and the non-diluted product from which it can
be made. The commercially available product from which the dilution is to
be prepared is the parent and the resulting diluted drug solution is the
child. The process of creating the child product should be sufficiently
flexible that the system 100 is able to use the best available parent for
the process and in particular, the system 100 (and the software thereof)
is able to handle the following scenarios: (1) there is no parent vial
already available on the hold location--the software should drop a new
parent vial from the drug cabinet 110 choosing the smallest vial that can
deliver the quantity of parent medication needed to prepare the child;
(2) there is no parent vial available on the hold location--there are
additional syringes that will be prepared directly from the parent vial,
in which case the software of the system 100 should drop a new parent
vial from the drug cabinet 110 choosing the smallest vial that can
deliver the quantity of parent medication needed to prepare the child and
the additional syringes; (3) a parent vial for the drug to be diluted is
already on the hold location and has sufficient supply to create the
dilution--the software of the system 100 should use the parent vial on
the hold location to prepare the child; and (4) a parent vial for the
drug to be diluted is already on the hold location and does not contain
sufficient drug to prepare the child--the software should drop a new
parent vial from the drug cabinet and should choose the smallest vial
that will permit preparation of the child. These aspects of the present
system 100 are described in greater detail below.

[0116] According to one embodiment of the present invention, the system
100 includes a method of dilution in which a formulary contains a product
definition and a container definition for each child product (dilution)
that can be prepared by the system 100. For example, a Clindamycin 5
mg/ml dilution in a 30 ml vial will exist in the formulary as Clindamycin
150 mg container and a Clindamycin 5 mg/ml, 30 ml product vial. The vial
product will be a specially marked product whose formulary definition
contains: (i) the product ID of a commercially available product from
which it is prepared, (ii) the volume of the commercial product needed to
prepare the dilution, and (iii) a volume of diluent needed to prepare the
final dilution.

[0117] The system 100 and in particular, the inventory tracking software
thereof, assigns each child product to a specific column in the drug
cabinet 110. That column in the drug cabinet 110 stores a sterile, empty
vial for use in preparing the dilution that is labeled with the drug
name, concentration, volume and bar code. The system 100 includes a vial
routine that assigns a vial to a syringe 10 when it is loaded onto the
dial 130 and has additional logic that determines vial suitability based
on the dose volume and concentration. This routine of the system 100
searches each product in the inventory for the requested drug and then
select the product that will provide the drug in the smallest measurable
volume.

[0118] If the selected drug is a dilution, the software of the system 100
will first cause the automated components of the system 100 to locate and
acquire the parent commercially available vial, reconstitute it, if
necessary, aspirate the defined volume from the parent vial and then park
the parent vial in an available hold location. If there are previously
loaded syringes 10 that will use an already-defined child vial that has
not yet been created but for which the entire vial has not been
committed, the software will assign the syringe 10 to that vial 60. If
there is already a vial 60 on a hold location (station 700) that contains
the same drug in the same concentration as the designated parent vial,
the software will use the vial on the hold location to prepare the child.
If there are previously loaded, unfilled syringes that are to be filled
from the parent vial directly, and there is spare capacity in the parent
vial, the software of the present system 100 prepares the child from the
parent vial assigned to those previously loaded syringes 10. If a new
child vial is needed, and a new parent vial is needed, the software of
the system 100 will query the queue for other syringes that can be
prepared from the parent vial. If a new child vial is needed, and a new
parent vial is needed, and no other parent supply is needed, the software
will drop a parent vial as the assigned parent from the formulary. If the
particular assigned parent is not available, the software of the system
100 locates another vial of the same drug and concentration that can be
used to prepare the child.

[0119] The software of the present invention then causes the automated
system 100 to "drop" an empty vial from the dilution product volume, and
inject the defined volume of drug followed by the required amount of
diluent to prepare the requested dilution. To speed up the operation, the
parent vial can be agitating while the empty is vial is dropped and
verified. If a child already exists on the hold location and it has
available capacity, no new child vial is dropped from the drug cabinet
110. If the child vial is not on the hold location, or if such a vial on
the hold location lacks capacity to fill the syringe 10, the software of
the system 100 drops a new child vial and prepares it from the parent
vial contents and diluent. For example, to prepare a 5 mg/ml solution of
Clindamycin from a commercially available 150 mg/ml solution, the present
system 100 injects 1 ml of the commercially available Clindamycin and 29
ml of diluent into a 30 ml empty vial labeled for the dilution.
Similarly, to prepare a 10 mg/ml Cefazolin solution from a 1 gm/5 ml (200
mg/ml solution), the system 100 is instructed to reconstitute the
Cefazolin at the fluid delivery station 170 as described herein, aspirate
1 ml from the reconstituted vial, acquire a 20 ml sterile empty vial,
inject the 1 ml of Cefazolin 200 mg/ml, followed by 19 ml of water to
create a 20-fold dilution. After agitating, the fluid in the mixer, the
software of the present system 100 then aspirates the final dose out of
the vial 60 and injects the dose into the syringe 10. Agitating the vial
in the mixer or between the grippers of the robotic transporter is likely
inadequate because the drug is already a liquid and would only require
flipping the vial once or twice.

[0120] The above process is described in detail with reference to FIG. 15
which shows a flowchart of the dilution process. It will be appreciated
that there are a number of advantages of the serial dilution capabilities
of the system 100 and in particular, the serial dilution functionality
permits customized drug solutions to be prepared from commercial drug
solutions and the need for such customized drug preparation can be
determined at run time (in real time) and if so, the automated system 100
can react to that need by preparing (if needed) the commercial drug
product and then using the commercial drug product (e.g., a reconstituted
medication) to prepare the custom drug solution.

[0121] It will be appreciated that in the above dilution process, each
dilution consumes two positions in the "parking lot" or holding station
700, one for the parent vial and one for the diluted vial. This makes it
likely that prepared dilutions that are not used immediately will be
discarded before they are consumed to make way for preparation of other
diluted products. One exception to this would be to store the parent vial
in the mixer 710 when it is not being used, especially, when the mixer
710 includes a pair of gripping elements between which the vial is
received and held. If all of the drug is used up in either of the vials
(parent and child), only one of the hold areas would need to be used. If
both of the vials (parent and child) are used up, none of the hold areas
would be used. Space in the drug cabinet 110 is to be committed for the
vials labeled for the diluted product. A column will be required for each
drug/concentration combination.

[0122] In another aspect of the present invention, a pharmacy-managed
method for labeling sterile empty vials for use in preparation of diluted
product as described above is preferable provided. The pharmacy requires
a separate process for printing labels with appropriate bar codes and
human-readable text on the labels, applying those labels to vials used
for dilution of the correct size, and verifying that the correct labels
were correctly applied.

[0123] In one embodiment of the present invention, the serial dilution
functionality of the present system 100 permits definition of a product
that can be prepared by diluting another product and includes the
following functionality: (a) only commercially available injections can
be used to prepare a dilution (that is, one cannot prepare one dilution
from another dilution); (b) the software of system 100 permits dilutions
up to 100-fold (e.g., a dilution containing 1 ml of commercially
available drug and 99 ml diluent); (c) the system software provides
traceability of both the diluted product and the parent product in a
preparation history log and optionally, a verification tab of the
software allows the user to view the parent vial images and child vial
images; (d) the system 100 scan inventoried products and selects the
product that provides the ordered drug in the smallest volume greater
than or equal to 0.5 ml and less than or equal to 10 ml; (e) the system
100 determines if the total amount of the drug and diluent is less than a
maximum final volume (e.g., a maximum of 11.5 ml)--and if it is, the
syringe can be used to prepare the dose (this can result in mixture
ratios of up to 23 to 1); (f) the system 100 shall maintain at least one
column of empty vials for each dilution product and dilution ratio that
can be prepared; (g) the system 100 detects the condition in which the
selected product is a diluted product and shall cause the dilution to be
prepared from a parent product; (h) if available, the system 100 uses a
partial vial from a hold location (hold station) or from the grippers of
the mixer if the vial is contained therein to prepare a diluted product;
(i) if needed, the system 100 reconstitutes the parent product according
to the instructions in its formulary record; (j) if needed, the system
100 clears two hold locations (at station 700) for dilution activities by
removing their current occupants and placing them in the restocking bin;
(k) the software of the system 100 aspirates the parent product volume
from the parent vial; (l) the system 100 injects the parent product
volume into the child vial; (m) the system 100 injects the prescribed
diluent volume into the child vial; (n) the system 100 is configured to
invert the vial three times to ensure mixing (this can be done in the
grippers of the robotic device to save time or in a mixer); (o) the
system 100 aspirates the required dose from the child vial and inject it
into the syringe; and (p) if there is more than the minimum residual
volume of the child product remaining after preparation of pending doses,
the system 100 stores the child product up to its expiration time at an
available location of the hold station 700.

[0124] The system 100 also is configured to reject the drug order and
print a pass-through label if: (1) there is no source container that can
provide the dose in a volume between 0.5 ml and 11.5 ml; (2) there is no
inventory of a parent drug for a selected diluted drug; (3) there are no
more vials in which to prepare a diluted drug; (4) the ordered final
volume is less than the required dose volume for all available products
of the specified drug.

[0125] More specifically, FIG. 15 sets forth a flowchart detailing one
exemplary process for performing serial dilution with the system 100 of
the present invention at the various stations thereof. At step 1000, a
vial order is received. At step 1002, it is determined whether a diluted
product is needed. If the product is not a diluted product, then at step
1004, it is determined whether the drug is to be reconstituted. If the
drug is to be reconstituted, then it is done so at step 1006. If the drug
is not to be reconstituted, then at step 1008, a dose volume of drug is
aspirated. At step 1010, it is determined whether additional dilution of
the aspirated dose volume is to be performed in the syringe. If so, then
the dose is diluted in the syringe itself at step 1012 and then the
process ends at step 1014. If additional dilution in the syringe is not
required, then the process ends at step 1014.

[0126] If at step 1002, it is determined that a diluted product is needed,
then at step 1016, it is determined whether the diluted product is being
held in the gripper (robotic arm or mixer). If so, then at step 1008, a
dose volume is aspirated therefrom. The process then goes to step 1010,
to determine whether additional dilution of the aspirated dose volume is
to be performed in the syringe. If so, then the dose is diluted in the
syringe itself at step 1012 and then the process ends at step 1014. If
additional dilution in the syringe is not required, then the process ends
at step 1014.

[0127] If the diluted product is not present in the gripper (step 1016),
then the system determines at step 1020 if the diluted product is present
on the hold platform (station 700). If the diluted product is at the hold
platform, then a diluent vial is retrieved at step 1022 and then the
process continues to steps 1008-1014.

[0128] If the diluted product is not present on the hold platform in step
1020, then the system 100 determines at step 1022 whether the parent
product is being held in the gripper (robotic arm). If the answer to step
1022 is yes, then the system determines at step 1024 whether the product
be diluted in the syringe (QSing the syringe) and if so, the process
continues to steps 1008-1014. If the product cannot be diluted in the
syringe, then at step 1026, an empty vial is dropped; at step 1028, the
dose volume is aspirated from the parent product; at step 1030, the dose
volume and diluent are injected into the empty vial and at step 1032, the
product is agitated in the grippers before the process continues to steps
1008-1014.

[0129] If the answer to step 1022 is no, then the system determines at
step 1034 whether the parent product is present on the hold platform
(station 700) and if so, then at step 1036, the parent vial is retrieved
from the hold platform before process continues to step 1024. If the
answer to step 1034 is no, then the parent vial is dropped at step 1038
and at step 1040, it is determined whether to reconstitute the drug. If
the drug is to be reconstituted, then it is done so at step 1042 before
the process continues to step 1024. If the drug is not to be
reconstituted, the process continues to step 1024.

[0130] FIG. 16 shows an exemplary computer screen display 1100 for
entering diluted product information. In this example, a diluted product
is being added to the software and in particular, in box 1101, the user
enters a drug description, in this case, "Oxacillin 100 mg Dilution" and
then the user in box 1102 selects an appropriate drug container, in this
case, "Oxacillin 100 mg". In box 1104, the user enters a unique drug
code, in this case, "12345678" and in box 1106, a bar code for the
diluted product is entered, in this case "12345678". In box 1107, the
reconstituted volume is entered, in this case, 10 ml and in box 1108, the
reconstituted concentration is added, in this case, 10 mg/ml. To add this
product to the software, a button 1110, such as an Add button, is
selected.

[0131] After this information is inputted, a series of formulary tests for
the diluted product entry is performed and in particular, the drug name
is looked up from the container. The system 100 searches all products
which are not dilutions and are the specified drug. A search is also
performed for a dilution ratio, such as a ratio between
1.ltoreq.ratio--100 (the ratio is equal to the concentration of the
parent/concentration of child in base units). A first match is accepted
on the first round if it passes all quality control inquiries. It will
also be appreciated that the software can be configured so that a
formulary product editor and verify screens shall limit the products that
can be used to serve as parent products to those that do not have the
dilution field selected as TRUE (products that are commercially available
and are not diluted products). Safety feature are preferably incorporated
into the software to restrict the manner in which a formulary upgrade is
performed. For example, an updated product file shall require
verification by a user, who is allowed to verify formulary changes (e.g.,
a pharmacist), before the update can be completed. After the medication
is aspirated into the barrel 20, the dial 130 is advanced so that the
filled syringe 10 is delivered to the sixth station 180 (FIG. 2). For
example, the dial 130 is preferably advanced so that the filled syringe
10 is delivered to a station where the removed tip cap 40 is replaced
back onto the barrel tip 28 by a device 900. The device 900 can be
similar or identical to the device 300 that removes the tip cap 40 from
the barrel tip 28 at an earlier station or the device 900 can be
different from the device 300 so long as the device 900 is configured to
grasp the tip cap 40 from the post 161 and then place the tip cap 40 back
on the barrel tip 28.

[0132] It will be appreciated, and as described above, that the system 100
and in particular, the reservoir mode station 770 thereof, is configured
to perform multiple plunger extension operations (sequential plunger
extensions) as illustrated in FIG. 7. For example, the syringe 10 is
delivered to the station 770 in an empty form and then the device 400
engages the plunger 50 and based on instructions and commands received
from the master controller, the device 400 extends the plunger 50 a first
predetermined distance (distance Y in FIG. 7) to draw in a prescribed
amount of a first fluid from a first fluid dispensing mechanism, such as
device 400, and then once the prescribed amount of first fluid is
delivered into the syringe 10, the device 400 operates to extend the
plunger 50 a second predetermined distance (distance X in FIG. 7) that
corresponds to a load volume or space that is intended to receive a
second fluid from a second fluid dispensing mechanism which is different
from the first fluid dispensing mechanism. Typically, the second fluid
dispensing mechanism is located downstream of the first fluid dispensing
mechanism and is configured to be able to reconstitute the medication.
The first fluid dispensing mechanism is preferably a device that is not
of the type that reconstitutes medication but instead, is of a type that
can deliver the first fluid (e.g., diluent for diluting a drug) in a
pumpless manner and the second fluid dispensing mechanism delivers the
second fluid without means of extending the plunger of the syringe.

[0133] While, in one embodiment, the extension of the plunger 50 is
controlled to a high degree of precision by using a servo motor (e.g.,
stepper motor) that is operated to cause movement of the plunger the
precise distance which results in the proper amount of fluid being drawn
into the syringe, other mechanisms are available to perform the same
function. In particular, a laser unit can be provided and positioned so
that a laser beam generated thereby is positioned and set to the fluid
level desired and then the fluid is added to the syringe until the laser
beam is broken at which time, the delivery of the fluid is stopped. Both
methods provide precise manners for delivering a prescribed, precise
volume of fluid to the syringe.

[0134] The first fluid is preferably a diluent that dilutes the drug
concentration in the second fluid to produce a final drug product that
has the precise concentration of medication. However, it will also be
understood that the first and second fluids contain two different drugs
and therefore, the final drug product is a combination of two drugs that
are drawn from two separate sources by means of extension of the plunger.

[0135] The capped syringe 10 can then be transferred to other stations,
such as a station where the syringe in bandolier form is cut into
individual syringes 10 that are labeled for particular patients. The
syringes 10 can then be unloaded from the dial 130 and then further
processed, as for example, by being delivered to a storage receptacle
where it is stored or by being delivered to a transporting device for
delivery to the patient or the filled syringes 10 can be cataloged and
packaged in different boxes or the like for delivery to one more
locations. For example, in a batch type process, which is typically more
common with the reservoir mode type of operation, a number of syringes 10
can be prepared and delivered into a single box or receptacle.

[0136] In yet another aspect of the present invention illustrated in FIGS.
10-12, the system 100 includes software that permits the user to enter
(input) drug vial information which is then used to calculate and control
the movement and position of the vented cannula 610 with respect to a
septum 61 of the drug vial 60. As previously mentioned, the vented
cannula 610 includes the drug delivery cannula portion and a separate air
vent channel that terminates in a vent port proximate the open cannula
portion. In order for the vent portion to be in an active, open position,
the vent port must be positioned within the interior chamber of the drug
vial 60 below the septum 61 so as to permit atmospheric air to travel
into the interior chamber (i.e., the interior is vented), thereby
allowing fluid (e.g., diluent) to be injected into the interior chamber
or reconstituted medication to be aspirated therefrom. It will be
appreciated that if the vent port is not positioned within the interior
chamber, then the vent feature is not active and diluent cannot be easily
added to the drug vial 60 to reconstitute the medication and
reconstituted cannot be easily aspirated from the interior chamber.

[0137] Thus, in order for the vent feature to be active, the cannula 610
must be positioned so that the vent port clears the septum and is
positioned below the septum 61 inside the interior chamber.

[0138] There are a number of different vial types 60 that are commercially
marketed by a number of different manufacturers. Not only do drug vials
60 come in different sizes (e.g., different volume sizes) and shapes, but
also, the drug vials 60 have different septum types 61. For example and
importantly, the thickness of the septum 61 can vary from one application
to another (e.g., from one vial 60 to another vial 60). Thus, if the
thickness of septum A is 5 units and the thickness of the septum B is 10
units, the computer control system and positioning system of the drug
delivery device and in particular, the cannula control unit, must take
this difference into account into to properly position the vent in the
correct location where it is active. For example, if the control system
simply moved and positioned the cannula in the same position for the
septums A and B, the vent port may clear the septum A but in the case of
septum B, the vent port may not clear the lower surface of the septum 61
but instead is located within the septum 61 itself and thus, be in an
inactive or closed position. Thus, it is clearly desirable for the
control and positioning system to be able to recognize the type of septum
61 that is being used with the particular drug vial 60 that is being
operated on by the system 100.

[0139] In accordance with one embodiment of the present invention, the
software of the control and positioning system includes a database that
stores pertinent information about the drug vial and in particular,
pertinent information about the septum 61. As shown in FIG. 16, the
computer screen 1100 can include a number of input boxes in which the
operator can enter certain vial characteristics, such as the vial width,
height, and septum distance (thickness). The database can store the
dimensions of the septum 61, especially, the thickness of the septum 61.
This stored information is used to control the positioning of the cannula
610 and in particular, to control the precise location of the open tip
and vent port of the cannula 610 with respect to the septum contained in
the drug vial 60.

[0140] More specifically and during the initial input of information
(e.g., using a keyboard, etc.), the user can enter not only information
about the drug product order but also information about the drug vial 60.
For example, the user can enter that the drug vial 60 is a 50 ml vial
type X from company Y. Alternatively, the type of drug vial 60 can be
inputted by means of scanning the barcode or the like that is contained
on the drug vial 60. In the embodiment, the initial scan of the barcode
transfers to the master controller not only information about the
contents of the drug vial 60 but also transfers to the master controller
information about the drug vial type.

[0141] Once the master controller receives the inputted or read
information about the vial type, the master controller searches the
database for this particular vial type and once it is found in the
database, the related stored information in the database is retrieved and
is used to control the positioning of the cannula unit. In particular,
the dimensions, and particularly, the thickness and diameter of the
septum 61, are used in the calculation of how far the cannula is lowered
with respect to the drug vial 60 so as to ensure that not only the open
drug delivery portion of the cannula 610 but also the vent port of the
cannula 610 completely clear the septum so that both of these features
are positioned within the interior chamber of the drug vial 60 (FIG. 12).
This results in the vent port being in an active position to ensure
proper venting of the interior chamber of the drug vial 60 to atmospheric
air to permit either diluent to be added to the drug vial 60 to
reconstitute the medication or the aspiration of the fluid (e.g.,
reconstituted medication) from the drug vial 60.

[0142] Accordingly, by accessing the vial characteristics stored in memory
based on the inputted or read vial identifying information, the computer
system determines a precise load location where the vent port is open
(active venting) by being located completely within the interior chamber
below the septum 61 as in FIG. 12 and a second position where the vent
port is closed as in the case where venting of the interior chamber is
not desired as in FIG. 11. The computer software can use a coordinate
mapping system or other drive technology to position the cannula with
preciseness at one of these positions. This permits the position of not
only the open end tip of the cannula, but also the vent port, to be
tracked at all times relative to the septum 61 since the thickness of the
septum 61 is stored in the database and thus, it can easily be calculated
the precise location where the cannula tip needs to be driven in order to
clear the septum 61 and similarly, the location that the vent port needs
to be driven to in order to clear the septum 61 and be engaged (open or
active).

[0143] It will be appreciated that the above process is not limited to the
use of the vented cannula 610 but applies instead to the use of any
vented instrument, such as a vented syringe tip, etc.

[0144] In another aspect, the stored vial characteristic information can
contain information about the angle draw of the fluid (reconstituted
medication) contained in the vial 60. For example, different septum
designs have different preferred positions of an angle of drawing the
reconstituted medication from the drug vial interior. For example, one
draw angle is 90 degrees in which the cannula 610 is inserted through the
septum 61 at a 90 degree angle and then the medication is drawn through
the cannula 610 from the interior chamber. If the draw angle is 45
degrees for a particular vial and septum 61, then the cannula 610 is
inserted through the septum 61 and the vial 60 (with cannula) is rotated
to a 45 degree angle relative to a ground surface, etc. The reconstituted
medication is then drawn from the vial 60 at this angle.

[0145] Once again, it will be appreciated that in a typical drug drawing
operation, the vented needle 610 (cannula) is placed in a multitude of
positions in order to optimize the amount of drug that is being drawn
from the vial 60. For example, in the initial drug drawing operation, the
vent is engaged by clearing the septum 61 to permit the medication (e.g.,
reconstituted medication) to be drawn from the drug vial 60. The computer
system can be programmed so that once a substantial amount of the drug
has been drawn and only a small amount remains in the vial 60, the vent
is not engaged to permit the last small amount of drug to be drawn from
the vial 60. In other words, the automated positioning system (e.g.,
coordinate tracking system) can be used to position the tip of the
cannula just through the septum 61 in order to get every last drop of
medication from the vial 60.

[0146] In addition, the repeated piercing of the septum 61 in the same
location by the cannula 610 can cause coring to occur due to the exposed
septum being repeatedly penetrated at the same location which causes
small pieces of the rubber septum 61 to dislodge. This is especially the
case for multi-dose vials 60 that are used multiple times. To prevent
coring of the septum 60, the system 100 can include a multi-position
septum penetration feature in which software records, stores and controls
the location where the piercing object (such as cannula 610 or a needle
of the syringe 10) pierces the septum 61. As previously described and in
the case of the cannula unit 590, for example, a master controller
controls the movements of the cannula unit 590 and in particular,
controls the vertical motion of the cannula unit 590 so that the cannula
610 is delivered to the correct location inside the vial 60 and relative
to the septum 61. However, in order to eliminate the coring problem, the
master controller is configured to control the entry point or location of
the entry of the piercing object into the septum 61. In other words, the
same location of the septum 61 is not repeatedly pierced by the inserted
object but instead, the cannula unit 590 is controlled so that the unit
590 moves laterally relative to the septum 61 to cause the cannula 610 to
enter a different location of the septum 61.

[0147] For example, the software associated with the master controller can
contain a program and a database that keeps track of the prior locations
where a particular vial that is uniquely identified has been pierced and
it also contains a stored piercing pattern that includes multiple
piercing points that have different mapped coordinates so that they do
not overlie one another and therefore, successive piercings of the same
septum 61 result in the piercing object contacting and entering different
locations (coordinates) of the septum 61 as illustrated in FIG. 10. Thus,
as soon as the multi-use drug vial 60 is identified by its unique
identifier (e.g., a barcode, RFID, etc.), the controller accesses the
database and retrieves the stored past history of the septum piercing
locations for this particular septum 61 and then, it determines the next
piercing location and instructs the fluid delivery unit to move the
piercing object to that location. As viewed from the top, the septum can
be pierced in a number of randomly scattered locations. In another
example, the master controller uses the information about the material
characteristics of the septum of a given vial in the database, and
adjusts the speed of insertion of cannula through the septum. In other
words, the master controller can control the cannula so that it has a
relatively faster speed to penetrate a hard septum to minimize coring.

[0148] In yet another feature of one embodiment of the present invention,
the system 100 can include software that includes a computer display that
permits the operator to easily determine at any given time the location
and status of each syringe 10 as it advances through the automated system
as illustrated in FIG. 13. In particular, the system 100 has a video
display 1001 that displays the movements of the components of the system
100 in real time so that the user can monitor and track the drug delivery
devices (e.g., syringes or bags) as they are advanced from one station to
a next station. For example, the system 100 typically includes a keyboard
or pad or the like that permits the operator to input certain data, such
as, the drug order contents, the drug vial information, etc., and it
includes a display or monitor that permits the operator to graphically
view all this information in real time.

[0149] FIG. 13 is a screen shot or image of an exemplary video display in
which the various stations of the system 100 are identified, as well as
the conveyor or transporter (in this case, the dial 13), that moves the
drug delivery devices. In particular, the precise locations of the
syringes around the dial 130 are indicated by a closed circle outline 13
in FIG. 13, however, it will be appreciated that other shapes can equally
be used to illustrate the location of the syringes 10. As will be
appreciated, these circle outlines 13 represent pockets or nests around
the dial 130 where the syringes 10 are inserted and held in place as the
dial 130 is advanced to move the syringes from one location to another
location.

[0150] If a particular pocket or nest is empty and does not include a
syringe 10, then the circle outline 13 at this location remains empty and
is not "filled" with color so as to indicate the presence of a syringe
10. When a syringe 10 is fed into and held within a particular pocket or
nest, the circle is shown as a filled circle 15 of any given first color.
In this manner, the empty circle identifiers 13 around the dial 130
represent areas where no syringe is present and the filled circle 15
identifiers represent locations where syringes 10 are present.

[0151] In another aspect, the color of the filled circles 13 can change
based on whether the syringe that is located at this particular location
is undergoing some type of operation and is thus, at an active station or
whether, the syringe 10 at this location is inactive and is waiting to be
advanced to a next station where an operation is to be performed. For
example, a loaded inactive syringe 10 can be identified on the screen by
a blue colored circle 15 and when this loaded syringe 10 is advanced to
an active station where some type of operation is performed on the
syringe (e.g., decapping of the syringe, filling or aspiration of
medication, etc.), the color of the circle 13 changes from blue to green
to indicate that this particular syringe is at an active station and is
being subjected to some type of operation. This is represented as a green
colored circle 17. As soon as the operation has stopped, the color of the
circle 13 returns back to blue to indicate an inactive site.

[0152] It will also be appreciated that each syringe 10 can be identified
by a tag 19 on the display screen that contains a unique identifying code
to permit the operator to easily and quickly determine which syringe 10
is located at each station. For example, the tag 19 can be visual tag
that is displayed on the screen next to the circle 13 that identifies a
loaded syringe and as the transporter (dial) is advanced, the tag 19
moves along with the depiction of the syringe (e.g., the filled-in circle
identifier). The unique identifying code can be chosen by the computer
software and linked to the syringe barcode, etc., or the identifying code
can be the barcode itself.

[0153] In contrast to conventional automated syringe handling systems, the
system 100 is not restricted to being operated in a sequential manner
where one syringe is fed from one station to the next but instead, the
system 100 is configured so that there can be a number of active work
stations performing some type of automated operation at the same time.
Thus, at any given time, the video display can show two or more green
colored syringe identifiers to indicate that two or more syringes are at
active stations where work is occurring. For example, in the serial
dilution mode of operation, both the reservoir mode station 770 and the
fluid transfer station 170 can be and preferably are active at any one
point in time and therefore, the visual syringe identifiers at these two
stations will be colored green on the visual display to show that work is
being performed on these syringes at the given stations. In addition, one
syringe may be undergoing a decapping operation at station 150, while at
the same time, another syringe is receiving a dosage of medication at the
fluid transfer station 170 and therefore, the visual syringe identifiers
for these two syringes will be green colored. It will be appreciated that
there is no limit as to the number of stations that can be active at the
same point in time and therefore, in contrast, to conventional design,
the present invention is a multi-station operation that is not limited to
being a sequential operation where a gripper or robotic device delivers
one syringe from one station to another station until all operations have
been performed on the syringe and then at that point in time, the robotic
device will get another empty syringe and start the sequential process
over. However, this type of process is a sequential process where only
after work is completed on one syringe does work start on the next
syringe.

[0154] In yet another safety feature of the present invention illustrated
in FIGS. 2 and 9, syringes that are present at a set interval are removed
from the dial 130 just prior to the unloading station 200 and are
delivered via a robotic device 531 to a weigh station 201 where the
filled syringe is weighed. For example, every 10.sup.th syringe or some
other syringe interval can be removed from the dial 130 and delivered to
the weigh station 201. The filled syringe 10 is then checked with a
stored value (target value) and if it is within a range of accepted
values, the syringe is then delivered back to the unloading station where
it is then removed from the dial 130 and placed on a conveyor or the
like. This safety feature is particularly useful and is intended for use
more when a batch of syringes having the same specifications is prepared
since checking syringes at predetermined intervals is a quality control
measurement for checking the integrity and precision of the batch filling
devices.

[0155] The software can be configured so that if one of the selected
syringes has a weight that is outside of the acceptable range, then not
only is this particular syringe discarded but the operator can be given
several safety feature options, including, modifying the interval at
which the syringes are checked so that the interval is decreased (e.g.,
instead of checking every 10.sup.th syringe, the system can be modified
to check every 3.sup.rd syringe, etc.); the operator can undertake a
check of the filled syringes that exited the system 100 for a given
preceding time period; etc.

[0156] As shown in FIG. 1, the system 100 is typically incorporated into
the housing 1300, such as a cabinet, that has different compartments for
storing the components of the system 100. For example and as shown in
FIG. 1, the housing can include a first space 1310 in the form of the
drug cabinet 110 that stores the drug vials 60 (FIG. 6), as by storing
them vertically in a number of different rows. The drug cabinet 110
preferably includes sensors and the like for indicating when a row of
drug vials 60 is low or has run out. The mechanism 510 (FIG. 2) that
transports an individual drug vial 60 from the drug cabinet 110 to the
other working components that are located in a second space 1320 of the
housing 1300 is located along one side of the housing 1300.

[0157] The other working components of the system 100 that are disposed in
the second space 1320 are accessible through one or more side windows
1322 and preferably, each side of the housing 1300 includes slideable
doors or windows 1322. When the doors 1322 are shut, the interior of the
housing 1300 is sealed. Since a number, if not all, applications,
especially, the preparation of chemotherapy drugs, require a sterile
environment, the housing 1300 includes one or more filters 1332 and in
particular, one or more HEPA filters 1332 (high efficiency particulate
absorbing filters) that are typically designed to remove at least 99.97%
of dust, pollen, mold, bacteria and any airborne particles with a size of
0.3 micrometers at 85 liters per minute.

[0158] In one embodiment, the housing 13000 has the HEPA filtration system
1332 incorporated into a ceiling or roof 1340 of the housing 1300 and
includes one or more HEPA filters 1332. The HEPA filter 1332 functions to
filter air that enters the cabinet by any number of different means,
including the opening of one glass door 1322. The HEPA filtration system
1332 also includes at least one and preferably a plurality of
sensors/sensing devices, such as particulate sensors, 1350 that
continuously monitor the conditions inside the housing 1300 and more
specifically, measure the level of particulates within the housing 1300.
The sensors 1350 can be placed in a number of different target locations
within the housing 1300. For example, one sensor 1350 can be located on
the ceiling/roof, one can be located on a side wall of the housing, one
can be located on a floor of the second space, etc.

[0159] The sensors 1350 communicate with the master controller which is
configured to continuously monitor the readings from the sensors and if
one reading, such as particulate count, is outside an acceptable range,
then the master controller takes appropriate action which can be to alert
the operator and/or take remedial action in an attempt to correct the
matter. For example, the alert can be in the form of an alarm (audible
and/or visual) that alerts the operator that an error or undesired
condition exists in the housing or with the system 100. The alert can
also be in the form of a text message, such as an email, that is sent to
one or more recipients to alert them of the current unacceptable
condition. Conventional wireless or wired communications equipment can be
provided to perform this function.

[0160] The alert functionality and error display functionality is not
limited to instances where a high particulate count is observed but it
can be a result of any other type of error situation, including a jam at
the loading station 120 or that the machine has run out of a feed of
syringes 10 or a jam has occurred at another station or a measured
parameter is outside an acceptable range.

[0161] In one embodiment, the housing 1300 includes a visual alert device
1352, such as a flashing light or solid color light, that is positioned
near the top of the housing so that anyone in the area of the housing
1300 can see when it is activated and is flashing to alert the operator
to check the visual display (computer monitor) for an error message that
details what problem or error has been detected. For example, during
normal operation, the light 1352 is a green color; however, when there is
a problem or error, the light 1352 has a red color and can also blink,
etc., or remain a solid color.

[0162] Once the light 1352 flashes, the operator can ascertain the reason
for the activation of the light by looking at the computer screen since
preferably, there is a section (e.g., a lower portion of the screen) that
lists any current error message. For example, the display could indicate
"Error Message 002-Jam at Syringe Feed Station" or "Error Message
005-High Particulate Reading at Sensor 001" or "Error Message 006-Syringe
Cap not detected at Station 0033," etc. Proper remedial action can then
be taken.

[0163] In yet another safety feature, the drug cabinet 110 can be
constructed so that is can receive a cleaning solution that is intended
to decontaminate the drug cabinet 110. For example, any wiring that is
exposed in the drug cabinet 110 can be routed through protective sleeves
or is otherwise protected and the drug cabinet 110 can include one or
more devices that are intended to dispense fluid in a controlled manner
through the drug cabinet, including the drug vials 60, contained therein.
For example, the devices can be in the form of misting devices or
sprayers that are fluidly connected to both a source of decontaminating
fluid and a controller that controls the dispensing of the fluid. The
controller is operatively connected to the master controller (computer)
and therefore is a programmable device that can be programmed to dispense
fluid at regular intervals. For example and depending upon applicable
regulatory requirements, the controller can be set up to cause a spraying
of decontaminating fluid within the drug cabinet 110, including over the
stored drug vials 60, at a precise time interval, such as daily, weekly,
monthly, etc. and for a programmable amount of time.

[0164] Any number of different decontaminating fluids can be used with one
exemplary embodiment being alcohol.

[0165] The drug cabinet 110 can thus contain a drain or the like to
collect any decontaminating fluid that may have run off the equipment in
the drug cabinet, including the vials. The drain can then lead to a waste
receptacle.

[0166] It will be appreciated by persons skilled in the art that the
present invention is not limited to the embodiments described thus far
with reference to the accompanying drawings; rather the present invention
is limited only by the following claims.